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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

Brief Summary:

Chronic musculoskeletal pain is an important problem, and treatments are often prescribed in a "trial and error" fashion. Clinicians prescribe a treatment to a patient and then wait and see if the treatment is successful. If the treatment is unsuccessful, they will try a different treatment. The disadvantage to this method is that it may take a long time to find a successful treatment.

The purpose of the PREEMPT Study is to test whether using a mobile phone application ("Trialist app") that allows patients and their health care providers to run personalized experiments comparing two pain treatments is more effective than usual care. Patients download the app, and working with their clinicians, set up a personalized trial that makes sense for them. Every day they answer questions to track levels of pain and side effects of treatment, such as fatigue and constipation. Once the personalized trial has ended, the responses to these daily questions on each treatment will be compared. During a regular clinic visit, the patient and the clinician will review visual displays of the results to facilitate treatment decision-making. Approximately 250 patients will be enrolled in the study. Half the patients will use the app and review results with the clinician, and half the patients will continue with their regular care (i.e., will not use the app). The two groups will be compared to see if using the app is successful in improving long term pain outcomes. The goal of the intervention using the Trialist app is to help patients engage actively and collaboratively with their clinicians and identify effective treatments more quickly.


Condition or disease Intervention/treatment Phase
Musculoskeletal Pain Chronic Pain Behavioral: Trialist Intervention Device: smartphone Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: N-of-1 Trials Using mHealth in Chronic Pain Aka PREEMPT (Personalized Research for Monitoring Pain Treatment)
Study Start Date : July 2014
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Trialist Intervention
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.
Behavioral: 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.
Other Names:
  • Trialist smartphone app
  • mobile health

Device: smartphone
No Intervention: Control-Usual Care
Receive usual care from clinician for chronic pain, do not use Trialist smartphone app



Primary Outcome Measures :
  1. Change From Baseline in Pain-related Interference on the Patient Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks [ Time Frame: baseline, 26 weeks ]
    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.


Secondary Outcome Measures :
  1. Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale [ Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks ]
    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.

  2. Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale [ Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks ]
    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.

  3. Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale [ Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks ]
    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.

  4. Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale [ Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks ]
    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.

  5. Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire [ Time Frame: Baseline, 13 weeks, 26 weeks, 52 weeks ]
    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.

  6. Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire [ Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks ]
    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.

  7. Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale [ Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks ]
    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.

  8. Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information [ Time Frame: Baseline, 13 weeks, 26 weeks, 52 weeks ]
    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.

  9. Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care [ Time Frame: Baseline, 13 weeks, 26 weeks, 52 weeks ]
    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.

  10. Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication [ Time Frame: Baseline, 13 weeks, 26 weeks, 52 weeks ]
    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.


Other Outcome Measures:
  1. Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    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.

  2. Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    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.

  3. Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    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.

  4. Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    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.

  5. Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    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.

  6. Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    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.

  7. Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    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.

  8. Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    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.

  9. Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 26 Weeks [ Time Frame: Baseline, 26 weeks ]
    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.

  10. Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 26 Weeks [ Time Frame: 26 weeks ]
    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.

  11. Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    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.

  12. Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    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.

  13. Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    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.

  14. Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    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.

  15. Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    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.

  16. Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    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.

  17. Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    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.

  18. Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    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.

  19. Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    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.

  20. Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 13 Weeks [ Time Frame: Baseline, 13 weeks ]
    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.

  21. Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    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.

  22. Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    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.

  23. Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    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.

  24. Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    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.

  25. Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    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.

  26. Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    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.

  27. Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    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.

  28. Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    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.

  29. Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    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.

  30. Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    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.

  31. Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 52 Weeks [ Time Frame: Baseline, 52 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic musculoskeletal pain (e.g., neck, back, extremities) operationalized as pain present for 6 weeks or more and a pain score of 4 or higher (on a 0-to-10 scale) on at least one of three items from the PEG pain scale
  • Age 18-75 years
  • Own web-enabled Android or iOS phone with data plan
  • In judgment of treating clinician, pain potentially amenable to treatment with acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), low-dose opioids, a complementary/alternative treatment such as massage or meditation, or a simple combination of these treatments
  • Ability to speak and read English

Exclusion Criteria:

  • Treated with surgery, radiation or chemotherapy for cancer in past 5 years
  • Other medical conditions that in clinician's judgment would limit life expectancy to less than 2 years or imperil patient safety
  • Pregnant or breastfeeding
  • Dementia, bipolar disorder, schizophrenia, active suicidality
  • Current alcohol or prescription drug abuse; history of disruptive behavior
  • Failed 5 or more analgesic medications because of lack of effectiveness or poor tolerability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116621


Locations
Layout table for location information
United States, California
Veteran's Administration-Northern California Health Care System
Mather, California, United States, 95655
University of California, Davis Medical Center
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
National Institute of Nursing Research (NINR)
Investigators
Layout table for investigator information
Principal Investigator: Richard L Kravitz, MD, MSPH University of California, Davis
  Study Documents (Full-Text)

Documents provided by University of California, Davis:

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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 Posted: April 17, 2014    Key Record Dates
Results First Posted: May 25, 2018
Last Update Posted: May 25, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of California, Davis:
Musculoskeletal pain
Chronic pain
Patient centered outcomes research
Physician patient relationship
Mobile applications

Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Musculoskeletal Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases