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N-of-1 Trials Using mHealth in Chronic Pain (PREEMPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02116621
Recruitment Status : Completed
First Posted : April 17, 2014
Results First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of California, Davis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions Musculoskeletal Pain
Chronic Pain
Interventions Behavioral: Trialist Intervention
Device: smartphone
Enrollment 215
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Period Title: Baseline
Started 108 107
Completed Baseline Visit 108 103
Completed Intervention Period 95 103
Completed 108 103
Not Completed 0 4
Reason Not Completed
Withdrawal by Subject             0             4
Period Title: Three Month Follow-up
Started 108 103
Completed 89 96
Not Completed 19 7
Reason Not Completed
Death             1             1
Withdrawal by Subject             4             1
Lost to Follow-up             0             1
Did not complete follow-up survey             14             4
Period Title: Six Month Follow-up
Started 103 [1] 100 [2]
Completed 99 97
Not Completed 4 3
Reason Not Completed
Withdrawal by Subject             1             1
Lost to Follow-up             2             1
Did not complete follow-up survey             1             1
[1]
Patients who didn't complete 3mo survey but didn't drop from study were contacted for 6mo follow-up.
[2]
Patients who didn't complete 3mo survey but didn't drop from study were contacted for 6mo follow-up
Period Title: Twelve Month Follow-up
Started 100 [1] 98 [1]
Completed 84 86
Not Completed 16 12
Reason Not Completed
Withdrawal by Subject             1             0
Lost to Follow-up             0             1
Did not complete follow-up survey             1             3
Enrolled within 12 months of study end             14             8
[1]
Patients who didn't complete 6mo survey but didn't drop from study were contacted for 12mo follow-up
Arm/Group Title Trialist Intervention Control-Usual Care Total
Hide Arm/Group Description

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app Total of all reporting groups
Overall Number of Baseline Participants 108 107 215
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 107 participants 215 participants
55.4  (10.8) 55.6  (11.5) 55.5  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 107 participants 215 participants
Female
50
  46.3%
52
  48.6%
102
  47.4%
Male
58
  53.7%
55
  51.4%
113
  52.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 107 participants 215 participants
Hispanic or Latino
16
  14.8%
8
   7.5%
24
  11.2%
Not Hispanic or Latino
91
  84.3%
95
  88.8%
186
  86.5%
Unknown or Not Reported
1
   0.9%
4
   3.7%
5
   2.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 107 participants 215 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
8
   7.4%
4
   3.7%
12
   5.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
  11.1%
15
  14.0%
27
  12.6%
White
75
  69.4%
80
  74.8%
155
  72.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
13
  12.0%
8
   7.5%
21
   9.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 108 participants 107 participants 215 participants
108
 100.0%
107
 100.0%
215
 100.0%
Pain interference   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 108 participants 107 participants 215 participants
64.0  (5.9) 64.7  (5.8) 64.3  (5.8)
[1]
Measure Description: Pain interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference.
Pain intensity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 108 participants 107 participants 215 participants
53.5  (5.4) 53.8  (5.1) 53.7  (5.2)
[1]
Measure Description: Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity.
Global physical health   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 108 participants 107 participants 215 participants
42.5  (6.8) 40.6  (5.5) 41.6  (6.2)
[1]
Measure Description: Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health.
Global mental health   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 108 participants 107 participants 215 participants
44.9  (9.1) 43.2  (7.9) 44.1  (8.6)
[1]
Measure Description: Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health.
Analgesic adherence (overuse)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 108 participants 107 participants 215 participants
90.2  (12.4) 89.4  (13.4) 89.8  (12.9)
[1]
Measure Description: Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications.
Analgesic adherence (underuse)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 108 participants 107 participants 215 participants
75.2  (22.3) 75.6  (24.6) 75.4  (23.4)
[1]
Measure Description: Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication.
Trust in clinician   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 108 participants 107 participants 215 participants
76.8  (15.8) 75.3  (17.1) 76.1  (16.4)
[1]
Measure Description: Patient trust in physician measured with 11-item Trust in Physician Scale to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment.
Satisfaction with pain information   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 108 participants 107 participants 215 participants
50.5  (38.8) 50.7  (37.8) 50.6  (38.2)
[1]
Measure Description: The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain.
Satisfaction with medical care   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 108 participants 107 participants 215 participants
84.7  (15.7) 79.5  (19.2) 82.2  (17.7)
[1]
Measure Description: The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care.
Satisfaction with pain medication   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 108 participants 107 participants 215 participants
65.2  (22.1) 63.4  (23.6) 64.4  (22.8)
[1]
Measure Description: The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications.
Medication related shared decision making   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 108 participants 107 participants 215 participants
74.3  (23.8) 75.0  (24.3) 74.6  (23.9)
[1]
Measure Description: Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making.
1.Primary Outcome
Title Change From Baseline in Pain-related Interference on the Patient Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks
Hide Description Pain interference measured with Patient Reported Outcomes Measurement Information System (PROMIS) Scale 8-item short form at baseline and 26 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.
Time Frame baseline, 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-3.22
(-4.31 to -2.13)
-1.85
(-2.96 to -0.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value -1.36
Confidence Interval (2-Sided) 95%
-2.91 to 0.19
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.
2.Secondary Outcome
Title Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale
Hide Description Pain-related Interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) scale 8-item short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.
Time Frame baseline, 13 weeks, 26 weeks, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change from baseline to 13 weeks
-2.70
(-3.83 to -1.57)
-1.91
(-3.02 to -0.81)
Change from baseline to 26 weeks
-3.22
(-4.31 to -2.13)
-1.85
(-2.96 to -0.75)
Change from baseline to 52 weeks
-2.67
(-3.82 to -1.52)
-2.83
(-3.98 to -1.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Other Statistical Analysis Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: -0.79 (-2.37 to 0.80); baseline to 26 weeks: -1.36 (-2.91 to 0.19); baseline to 52 weeks: 0.16 (-1.47 to 1.79)
3.Secondary Outcome
Title Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale
Hide Description Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.
Time Frame baseline, 13 weeks, 26 weeks, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change from baseline to 13 weeks
-1.60
(-2.67 to -0.54)
-1.92
(-2.96 to -0.87)
Change from baseline to 26 weeks
-2.86
(-3.89 to -1.83)
-1.46
(-2.50 to -0.41)
Change from baseline to 52 weeks
-3.00
(-4.08 to -1.91)
-1.76
(-2.85 to -0.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Other Statistical Analysis Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 0.31 (-1.18 to 1.81); baseline to 26 weeks: -1.41 (-2.87 to 0.06); baseline to 52 weeks: -1.24 (-2.77 to 0.30)
4.Secondary Outcome
Title Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale
Hide Description Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, and 52 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.
Time Frame baseline, 13 weeks, 26 weeks, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change from baseline to 13 weeks
-0.35
(-1.71 to 1.00)
0.30
(-1.02 to 1.63)
Change from baseline to 26 weeks
0.21
(-1.09 to 1.52)
-0.72
(-2.04 to 0.60)
Change from baseline to 52 weeks
0.36
(-1.01 to 1.74)
-0.39
(-1.76 to 0.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Other Statistical Analysis Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks:-0.66 (-2.55 to 1.24); baseline to 26 weeks: 0.93 (-0.92 to 2.79); baseline to 52 weeks: 0.76 (-1.19 to 2.70)
5.Secondary Outcome
Title Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale
Hide Description Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, 52 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.
Time Frame baseline, 13 weeks, 26 weeks, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change from baseline to 13 weeks
0.73
(-0.21 to 1.67)
0.44
(-0.48 to 1.35)
Change from baseline to 26 weeks
0.13
(-0.77 to 1.03)
0.30
(-0.61 to 1.21)
Change from baseline to 52 weeks
0.16
(-0.79 to 1.12)
0.42
(-0.53 to 1.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Other Statistical Analysis Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 0.30 (-1.01 to 1.61); baseline to 26 weeks: -0.17 (-1.45 to 1.12); baseline to 52 weeks: -0.26 (-1.61 to 1.09)
6.Secondary Outcome
Title Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire
Hide Description Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.
Time Frame Baseline, 13 weeks, 26 weeks, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change from baseline to 13 weeks
1.40
(-1.18 to 3.98)
0.35
(-2.15 to 2.85)
Change from baseline to 26 weeks
1.77
(-0.75 to 4.30)
-0.13
(-2.64 to 2.39)
Change from baseline to 52 weeks
1.61
(-1.02 to 4.24)
1.53
(-1.06 to 4.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Other Statistical Analysis Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.05 (-2.54 to 4.64); baseline to 26 weeks: 1.90 (-1.66 to 5.47); baseline to 52 weeks: 0.08 (-3.61 to 3.77).
7.Secondary Outcome
Title Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire
Hide Description Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.
Time Frame baseline, 13 weeks, 26 weeks, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change from baseline to 13 weeks
2.53
(-2.46 to 7.52)
-1.71
(-6.56 to 3.15)
Change from baseline to 26 weeks
1.88
(-3.00 to 6.76)
-2.76
(-7.63 to 2.11)
Change from baseline to 52 weeks
-3.53
(-8.62 to 1.56)
-1.62
(-6.66 to 3.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Other Statistical Analysis Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 4.24 (-2.73 to 11.20); baseline to 26 weeks: 4.64 (-2.25 to 11.54); baseline to 52 weeks: -1.91 (-9.07 to 5.26).
8.Secondary Outcome
Title Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale
Hide Description Patient trust in physician measured with 11-item Trust in Physician Scale at baseline, 13 weeks, 26 weeks, and 52 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.
Time Frame baseline, 13 weeks, 26 weeks, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change from baseline to 13 weeks
-2.49
(-5.44 to 0.46)
-4.25
(-7.13 to -1.36)
Change from baseline to 26 weeks
-2.30
(-5.14 to 0.54)
-4.84
(-7.73 to -1.96)
Change from baseline to 52 weeks
-4.00
(-7.00 to -0.99)
-5.53
(-8.52 to -2.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Other Statistical Analysis Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.76 (-2.37 to 5.89); baseline to 26 weeks: 2.55 (-1.50 to 6.60); baseline to 52 weeks: 1.53 (-2.70 to 5.77).
9.Secondary Outcome
Title Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information
Hide Description The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, and 52 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.
Time Frame Baseline, 13 weeks, 26 weeks, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change from baseline to 13 weeks
4.41
(-3.18 to 12.00)
-3.36
(-10.84 to 4.11)
Change from baseline to 26 weeks
11.28
(3.95 to 18.61)
3.99
(-3.47 to 11.45)
Change from baseline to 52 weeks
9.02
(1.28 to 16.76)
4.89
(-2.84 to 12.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Other Statistical Analysis Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 7.77 (-2.87 to 18.42); baseline to 26 weeks: 7.29 (-3.16 to 17.75); baseline to 52 weeks: 4.13 (-6.81 to 15.07).
10.Secondary Outcome
Title Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care
Hide Description The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.
Time Frame Baseline, 13 weeks, 26 weeks, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change from baseline to 13 weeks
-4.00
(-7.56 to -0.44)
-6.15
(-9.64 to -2.66)
Change from baseline to 26 weeks
-2.26
(-5.68 to 1.17)
-5.57
(-9.04 to -2.09)
Change from baseline to 52 weeks
-4.52
(-8.13 to -0.90)
-5.51
(-9.12 to -1.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Other Statistical Analysis Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 2.15 (-2.84 to 7.13); baseline to 26 weeks: 3.31 (-1.57 to 8.19); baseline to 52 weeks: 1.00 (-4.11 to 6.11).
11.Secondary Outcome
Title Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication
Hide Description The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.
Time Frame Baseline, 13 weeks, 26 weeks, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change from baseline to 13 weeks
1.46
(-2.93 to 5.86)
-0.34
(-4.73 to 4.05)
Change from baseline to 26 weeks
-0.18
(-4.44 to 4.08)
1.39
(-2.99 to 5.77)
Change from baseline to 52 weeks
0.77
(-3.72 to 5.25)
-0.34
(-4.87 to 4.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Other Statistical Analysis Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.81 (-4.41 to 8.02); baseline to 26 weeks: -1.57 (-7.68 to 4.54); baseline to 52 weeks: 1.11 (-5.27 to 7.48).
12.Other Pre-specified Outcome
Title Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks
Hide Description Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 26 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.
Time Frame Baseline, 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.86
(-3.89 to -1.83)
-1.46
(-2.50 to -0.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value -1.41
Confidence Interval (2-Sided) 95%
-2.87 to 0.06
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.
13.Other Pre-specified Outcome
Title Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 26 Weeks
Hide Description Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.
Time Frame Baseline, 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.21
(-1.09 to 1.52)
-0.72
(-2.04 to 0.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
-0.92 to 2.79
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.
14.Other Pre-specified Outcome
Title Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 26 Weeks
Hide Description Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.
Time Frame Baseline, 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.13
(-0.77 to 1.03)
0.30
(-0.61 to 1.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-1.45 to 1.12
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.
15.Other Pre-specified Outcome
Title Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks
Hide Description Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.
Time Frame Baseline, 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.77
(-0.75 to 4.30)
-0.13
(-2.64 to 2.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 1.90
Confidence Interval (2-Sided) 95%
-1.66 to 5.47
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.
16.Other Pre-specified Outcome
Title Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks
Hide Description Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.
Time Frame Baseline, 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.88
(-3.00 to 6.76)
-2.76
(-7.63 to 2.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 4.64
Confidence Interval (2-Sided) 95%
-2.25 to 11.54
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.
17.Other Pre-specified Outcome
Title Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 26 Weeks
Hide Description Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 26 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.
Time Frame Baseline, 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.30
(-5.14 to 0.54)
-4.84
(-7.73 to -1.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 2.55
Confidence Interval (2-Sided) 95%
-1.50 to 6.60
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.
18.Other Pre-specified Outcome
Title Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 26 Weeks
Hide Description The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.
Time Frame Baseline, 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
11.28
(3.95 to 18.61)
3.99
(-3.47 to 11.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 7.29
Confidence Interval (2-Sided) 95%
-3.16 to 17.75
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.
19.Other Pre-specified Outcome
Title Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 26 Weeks
Hide Description The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.
Time Frame Baseline, 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.26
(-5.68 to 1.17)
-5.57
(-9.04 to -2.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 3.31
Confidence Interval (2-Sided) 95%
-1.57 to 8.19
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.
20.Other Pre-specified Outcome
Title Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 26 Weeks
Hide Description The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.
Time Frame Baseline, 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.18
(-4.44 to 4.08)
1.39
(-2.99 to 5.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value -1.57
Confidence Interval (2-Sided) 95%
-7.68 to 4.54
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.
21.Other Pre-specified Outcome
Title Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 26 Weeks
Hide Description Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 62 45
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
79.6
(74.9 to 84.3)
67.7
(58.7 to 76.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.9
Confidence Interval (2-Sided) 95%
2.59 to 21.24
Estimation Comments [Not Specified]
22.Other Pre-specified Outcome
Title Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks
Hide Description Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 13 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.
Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.70
(-3.83 to -1.57)
-1.91
(-3.02 to -0.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value -0.79
Confidence Interval (2-Sided) 95%
-2.37 to 0.80
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.
23.Other Pre-specified Outcome
Title Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks
Hide Description Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 13 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.
Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-1.60
(-2.67 to -0.54)
-1.92
(-2.96 to -0.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
-1.18 to 1.81
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.
24.Other Pre-specified Outcome
Title Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 13 Weeks
Hide Description Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.
Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.73
(-0.21 to 1.67)
0.44
(-0.48 to 1.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
-1.01 to 1.61
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.
25.Other Pre-specified Outcome
Title Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 13 Weeks
Hide Description Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.
Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.35
(-1.71 to 1.00)
0.30
(-1.02 to 1.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-2.55 to 1.24
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.
26.Other Pre-specified Outcome
Title Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks
Hide Description Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.
Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.40
(-1.18 to 3.98)
0.35
(-2.15 to 2.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
-2.54 to 4.64
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.
27.Other Pre-specified Outcome
Title Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks
Hide Description Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.
Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.53
(-2.46 to 7.52)
-1.71
(-6.56 to 3.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 4.24
Confidence Interval (2-Sided) 95%
-2.73 to 11.20
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.
28.Other Pre-specified Outcome
Title Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 13 Weeks
Hide Description Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 13 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.
Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.49
(-5.44 to 0.46)
-4.25
(-7.13 to -1.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 1.76
Confidence Interval (2-Sided) 95%
-2.37 to 5.89
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.
29.Other Pre-specified Outcome
Title Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 13 Weeks
Hide Description The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.
Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
4.41
(-3.18 to 12.00)
-3.36
(-10.84 to 4.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 7.77
Confidence Interval (2-Sided) 95%
-2.87 to 18.42
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.
30.Other Pre-specified Outcome
Title Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 13 Weeks
Hide Description The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.
Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-4.00
(-7.56 to -0.44)
-6.15
(-9.64 to -2.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 2.15
Confidence Interval (2-Sided) 95%
-2.84 to 7.13
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.
31.Other Pre-specified Outcome
Title Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 13 Weeks
Hide Description The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.
Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.46
(-2.93 to 5.86)
-0.34
(-4.73 to 4.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 1.81
Confidence Interval (2-Sided) 95%
-4.41 to 8.02
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.
32.Other Pre-specified Outcome
Title Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks
Hide Description Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.67
(-3.82 to -1.52)
-2.83
(-3.98 to -1.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-1.47 to 1.79
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.
33.Other Pre-specified Outcome
Title Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks
Hide Description Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 52 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-3.00
(-4.08 to -1.91)
-1.76
(-2.85 to -0.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value -1.24
Confidence Interval (2-Sided) 95%
-2.77 to 0.30
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.
34.Other Pre-specified Outcome
Title Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 52 Weeks
Hide Description Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 52 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.16
(-0.79 to 1.12)
0.42
(-0.53 to 1.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value -0.26
Confidence Interval (2-Sided) 95%
-1.61 to 1.09
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.
35.Other Pre-specified Outcome
Title Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 52 Weeks
Hide Description Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 52 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.36
(-1.01 to 1.74)
-0.39
(-1.76 to 0.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
-1.19 to 2.70
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.
36.Other Pre-specified Outcome
Title Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks
Hide Description Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 52 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.61
(-1.02 to 4.24)
1.53
(-1.06 to 4.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-3.61 to 3.77
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.
37.Other Pre-specified Outcome
Title Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks
Hide Description Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 52 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.
Time Frame Baseline, 52 weeks
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[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-3.53
(-8.62 to 1.56)
-1.62
(-6.66 to 3.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value -1.91
Confidence Interval (2-Sided) 95%
-9.07 to 5.26
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.
38.Other Pre-specified Outcome
Title Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 52 Weeks
Hide Description Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 52 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.
Time Frame Baseline, 52 weeks
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[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-4.00
(-7.00 to -0.99)
-5.53
(-8.52 to -2.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 1.53
Confidence Interval (2-Sided) 95%
-2.70 to 5.77
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.
39.Other Pre-specified Outcome
Title Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 52 Weeks
Hide Description The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.
Time Frame Baseline, 52 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
9.02
(1.28 to 16.76)
4.89
(-2.84 to 12.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 4.13
Confidence Interval (2-Sided) 95%
-6.81 to 15.07
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.
40.Other Pre-specified Outcome
Title Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 52 Weeks
Hide Description The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-4.52
(-8.13 to -0.90)
-5.51
(-9.12 to -1.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
-4.11 to 6.11
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.
41.Other Pre-specified Outcome
Title Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 52 Weeks
Hide Description The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 108 103
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.77
(-3.72 to 5.25)
-0.34
(-4.87 to 4.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in differences
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
-5.27 to 7.48
Estimation Comments Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.
42.Other Pre-specified Outcome
Title Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 52 Weeks
Hide Description Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description:

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Overall Number of Participants Analyzed 48 51
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
74.8
(69.0 to 80.6)
65.4
(57.7 to 73.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trialist Intervention, Control-Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.41
Confidence Interval (2-Sided) 95%
-0.15 to 18.96
Estimation Comments [Not Specified]
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trialist Intervention Control-Usual Care
Hide Arm/Group Description

Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.

Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphone

Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
All-Cause Mortality
Trialist Intervention Control-Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   1/108 (0.93%)   1/107 (0.93%) 
Show Serious Adverse Events Hide Serious Adverse Events
Trialist Intervention Control-Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   0/107 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Trialist Intervention Control-Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   0/107 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Richard Kravitz, MD, MSPH
Organization: University of California, Davis
Phone: 916-734-1248
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02116621     History of Changes
Other Study ID Numbers: 496804
R01NR001938 ( U.S. NIH Grant/Contract )
First Submitted: April 15, 2014
First Posted: April 17, 2014
Results First Submitted: February 27, 2018
Results First Posted: May 25, 2018
Last Update Posted: May 25, 2018