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Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS)

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ClinicalTrials.gov Identifier: NCT01757301
Recruitment Status : Completed
First Posted : December 28, 2012
Results First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Pain
Depression
Anxiety
Musculoskeletal
Fibromyalgia
Interventions Other: Assisted Symptom Management (ASM)
Other: Comprehensive Symptom Management (CSM)
Enrollment 296
Recruitment Details  
Pre-assignment Details Two participants were excluded from the study after enrollment. Both participants failed screening and were considered ineligible.
Arm/Group Title Assisted Symptom Management (ASM) Comprehensive Symptom Management (CSM)
Hide Arm/Group Description

There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.

Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.

This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).

Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).

Period Title: Overall Study
Started 147 147
Completed 134 133
Not Completed 13 14
Arm/Group Title Assisted Symptom Management (ASM) Comprehensive Symptom Management (CSM) Total
Hide Arm/Group Description

There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.

Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.

This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).

Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).

Total of all reporting groups
Overall Number of Baseline Participants 147 147 294
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 147 participants 147 participants 294 participants
57.9  (11.7) 56.9  (12.5) 57.4  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 147 participants 294 participants
Female
14
   9.5%
23
  15.6%
37
  12.6%
Male
133
  90.5%
124
  84.4%
257
  87.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 147 participants 294 participants
American Indian or Alaska Native
0
   0.0%
1
   0.7%
1
   0.3%
Asian
0
   0.0%
1
   0.7%
1
   0.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.7%
1
   0.3%
Black or African American
24
  16.3%
21
  14.3%
45
  15.3%
White
117
  79.6%
116
  78.9%
233
  79.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
6
   4.1%
7
   4.8%
13
   4.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 147 participants 147 participants 294 participants
147
 100.0%
147
 100.0%
294
 100.0%
1.Primary Outcome
Title Composite Z-score of Pain-anxiety-depression Severity
Hide Description The primary outcome measure is the composite z-score of the main pain, anxiety, and depression measures in this trial: the BPI, GAD-7, PHQ-9, respectively. A standard z-score is calculated for each scale as follows: subject's scale score minus the sample mean divided by the sample standard deviation. A composite pain-anxiety-depression score is the average of the standard z-scores for the 3 scales. This is a scale of effect size where 0 represents no change from baseline, and a negative number means improvement and a positive number means worsening. Each unit means one standard deviation change from the group at baseline. Practical minimum value= -2.0, maximum value= +2.0. Positive number indicates greater symptoms severity/worse outcomes.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.
Arm/Group Title Assisted Symptom Management (ASM) Comprehensive Symptom Management (CSM)
Hide Arm/Group Description:
There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules. Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.

This arm couples ASM with care management by a nurse physician team, thus testing "combined" therapy vs.

"monotherapy" (ASM only). Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).

Overall Number of Participants Analyzed 140 140
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.52  (1.05) -0.65  (0.94)
2.Secondary Outcome
Title Pain Average/Enjoyment of Life/General Activities Pain Scale (PEG)
Hide Description The PEG is a 3-item validated version of the Brief Pain Inventory. Minimum value = 0; maximum value = 10. Higher scores indicate greater symptom severity/worse outcomes.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.
Arm/Group Title Assisted Symptom Management (ASM) Comprehensive Symptom Management (CSM)
Hide Arm/Group Description:
There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules. Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.

This arm couples ASM with care management by a nurse physician team, thus testing "combined" therapy vs.

"monotherapy" (ASM only). Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).

Overall Number of Participants Analyzed 140 140
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.0  (1.9) 6.1  (2.0)
3.Secondary Outcome
Title Patient Health Questionnaire 9-item Depression Scale (PHQ-9)
Hide Description The PHQ-9 has been used in hundreds of research studies as a depression severity and outcome measure and, now translated into more than 80 languages, is among the most widely used depression measures in clinical practice. Minimum value = 0; maximum value = 27. Higher scores indicate greater symptom severity/worse outcomes.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.
Arm/Group Title Assisted Symptom Management (ASM) Comprehensive Symptom Management (CSM)
Hide Arm/Group Description:

There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.

Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.

This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).

Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).

Overall Number of Participants Analyzed 140 140
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.4  (5.9) 10.3  (5.3)
4.Secondary Outcome
Title Generalized Anxiety Disorder 7-Item Anxiety Scale (GAD-7)
Hide Description The GAD-7 is an anxiety severity measure, validated in several thousand primary care patients and increasingly used in clinical research and practice. It is also a good first-line measure for estimating the probability of 4 common anxiety disorders in primary care - generalized anxiety disorder, panic disorder, post-traumatic stress disorder, and social anxiety disorder. Minimum value = 0; maximum value = 21. Higher scores indicate greater symptom severity/worse outcomes.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.
Arm/Group Title Assisted Symptom Management (ASM) Comprehensive Symptom Management (CSM)
Hide Arm/Group Description:

There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.

Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.

This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).

Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).

Overall Number of Participants Analyzed 140 140
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.4  (6.2) 7.5  (5.4)
5.Secondary Outcome
Title Brief Pain Inventory (BPI)
Hide Description The BPI rates the intensity of pain on 4 items (current, worst, least, and average pain in past week), and the interference in 7 areas (mood, physical activity, work, social activity, relations with others, sleep, enjoyment of life). Minimum value = 0; maximum value = 10. Higher scores indicate greater symptom severity/worse outcomes.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.
Arm/Group Title Assisted Symptom Management (ASM) Comprehensive Symptom Management (CSM)
Hide Arm/Group Description:

There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.

Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.

This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).

Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).

Overall Number of Participants Analyzed 140 140
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.0  (2.3) 5.0  (2.2)
Time Frame SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
Adverse Event Reporting Description SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
 
Arm/Group Title Assisted Symptom Management (ASM) Comprehensive Symptom Management (CSM)
Hide Arm/Group Description

There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.

Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.

This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).

Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).

All-Cause Mortality
Assisted Symptom Management (ASM) Comprehensive Symptom Management (CSM)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/147 (0.68%)      2/147 (1.36%)    
Hide Serious Adverse Events
Assisted Symptom Management (ASM) Comprehensive Symptom Management (CSM)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/147 (12.24%)      30/147 (20.41%)    
Blood and lymphatic system disorders     
Diagnosis of Hodgkins Lymphoma  [1]  0/147 (0.00%)  0 1/147 (0.68%)  1
Hospitalization for polycythemia likely secondary to renal mass   0/147 (0.00%)  0 1/147 (0.68%)  1
Hospitalization for infection   1/147 (0.68%)  2 1/147 (0.68%)  1
Cardiac disorders     
Hospitalization for heart catheterization   2/147 (1.36%)  2 0/147 (0.00%)  0
ER visit for atypical chest pain  [2]  0/147 (0.00%)  0 2/147 (1.36%)  2
Hospitalization for heart stent placement   0/147 (0.00%)  0 1/147 (0.68%)  1
Endocrine disorders     
Hospitalization for thyroidectomy   1/147 (0.68%)  1 0/147 (0.00%)  0
Gastrointestinal disorders     
Hospitalization following emergency appendectomy   0/147 (0.00%)  0 1/147 (0.68%)  1
Hospitalization for diverticulitis   0/147 (0.00%)  0 2/147 (1.36%)  2
Hospitalization for gastroparesis   0/147 (0.00%)  0 1/147 (0.68%)  1
General disorders     
Hospitalization for Influenza   1/147 (0.68%)  1 0/147 (0.00%)  0
Hospitalization for substance abuse   0/147 (0.00%)  0 3/147 (2.04%)  3
Hospitalization for atypical chest pain   0/147 (0.00%)  0 1/147 (0.68%)  1
Infections and infestations     
Hospitalization for wound   1/147 (0.68%)  1 3/147 (2.04%)  4
Hospitalization following amputation of left leg  [3]  1/147 (0.68%)  1 0/147 (0.00%)  0
Injury, poisoning and procedural complications     
Broken kneecap * [4]  1/147 (0.68%)  1 0/147 (0.00%)  0
Hospitalization following fall from ladder  [5]  1/147 (0.68%)  1 0/147 (0.00%)  0
ER visit for fall   0/147 (0.00%)  0 2/147 (1.36%)  2
Surgery following dog attack injuries   1/147 (0.68%)  1 0/147 (0.00%)  0
Nervous system disorders     
Hospitalization for TIA *  1/147 (0.68%)  1 1/147 (0.68%)  1
Psychiatric disorders     
Endorsed Suicidal Thoughts   1/147 (0.68%)  1 0/147 (0.00%)  0
Hospitalization for Suicidal Behavior   0/147 (0.00%)  0 4/147 (2.72%)  4
Renal and urinary disorders     
Hospitalization for kidney stone   1/147 (0.68%)  1 0/147 (0.00%)  0
Hospitalization following renal failure *  0/147 (0.00%)  0 1/147 (0.68%)  1
Yearly surveillance for known prostate cancer   0/147 (0.00%)  0 1/147 (0.68%)  1
Respiratory, thoracic and mediastinal disorders     
Hospitalization for pneumonia   2/147 (1.36%)  2 2/147 (1.36%)  2
ER visit for trouble breathing   1/147 (0.68%)  1 0/147 (0.00%)  0
Hospitalization for pneumonitis   0/147 (0.00%)  0 1/147 (0.68%)  1
Hospitalization for COPD   0/147 (0.00%)  0 1/147 (0.68%)  2
Hospitalization for bronchitis   0/147 (0.00%)  0 1/147 (0.68%)  1
Hospitalization for pulmonary edema   0/147 (0.00%)  0 1/147 (0.68%)  1
Hospitalization for collapsed lung   0/147 (0.00%)  0 1/147 (0.68%)  1
Surgical and medical procedures     
Hospitalization for planned knee replacement   1/147 (0.68%)  1 0/147 (0.00%)  0
Hospitalization for planned angioplasty   1/147 (0.68%)  1 0/147 (0.00%)  0
Hospitalization for planned hip surgery   1/147 (0.68%)  1 1/147 (0.68%)  1
Hospitalization for planned hernia repair   2/147 (1.36%)  2 1/147 (0.68%)  1
Hospitalization for planned autologous fascial sling surgery   0/147 (0.00%)  0 1/147 (0.68%)  1
Hospitalization for planned septoplasty   0/147 (0.00%)  0 2/147 (1.36%)  2
Hospitalization following elective laminectomy/fusion   0/147 (0.00%)  0 1/147 (0.68%)  1
Hospitalized following stem cell transplant   0/147 (0.00%)  0 1/147 (0.68%)  1
Vascular disorders     
Diagnosis of deep vein thrombosis   0/147 (0.00%)  0 1/147 (0.68%)  1
Indicates events were collected by systematic assessment
[1]
Diagnosis made by GI following biopsy of lymph node during endoscopic ultrasound procedure.
[2]
Presented to ER with atypical chest pain. Normal evaluation and work up. Released in stable condition.
[3]
Participant had calcaneus removed which resulted in a bone infection. Left leg amputated as a result.
*
Indicates events were collected by non-systematic assessment
[4]
Kneecap broken after falling on ice. Received urgent treatment at local hospital and scheduled surgery to repair.
[5]
Hospitalized for pain control following fall from 10 foot ladder. Suffered several broken ribs.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Assisted Symptom Management (ASM) Comprehensive Symptom Management (CSM)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/147 (8.84%)      72/147 (48.98%)    
General disorders     
Known medication side effects   0/147 (0.00%)  0 61/147 (41.50%)  92
Psychiatric disorders     
Triggered Suicidal Ideation Screener  [1]  13/147 (8.84%)  17 16/147 (10.88%)  23
Indicates events were collected by systematic assessment
[1]
Responses were recorded as Adverse Events when participants responded Somewhat/Very Likely, or refused to answer how likely they were to act on their self-harm thoughts and/or if they reported nothing/no one to prevent them from self-harm.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Erica Evans
Organization: Richard L. Roudebush VA Medical Center
Phone: 317-988-3476
EMail: erica.evans2@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01757301    
Other Study ID Numbers: IIR 12-095
First Submitted: December 20, 2012
First Posted: December 28, 2012
Results First Submitted: August 8, 2018
Results First Posted: March 13, 2019
Last Update Posted: March 13, 2019