Trial Outcomes & Findings for COMRADE: Collaborative Care Management for Distress and Depression in Rural Diabetes (NCT NCT02863523)
NCT ID: NCT02863523
Last Updated: 2023-12-08
Results Overview
Change from baseline in HbA1c or glycosylated hemoglobin (%)
COMPLETED
NA
139 participants
Baseline to 12 months
2023-12-08
Participant Flow
Participant milestones
| Measure |
Integrated Behavioral Intervention
Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.
Integrated Behavioral Care: Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.
|
Usual Care
Patients receive usual care
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
72
|
|
Overall Study
COMPLETED
|
67
|
72
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COMRADE: Collaborative Care Management for Distress and Depression in Rural Diabetes
Baseline characteristics by cohort
| Measure |
Integrated Behavioral Intervention
n=67 Participants
Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.
Integrated Behavioral Care: Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.
|
Usual Care
n=72 Participants
Patients receive usual care
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.67 years
STANDARD_DEVIATION 9.67 • n=5 Participants
|
54.71 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
53 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or mixed race
|
14 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
67 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
HbA1c
|
9.8 percent
STANDARD_DEVIATION 2.1 • n=5 Participants
|
9.3 percent
STANDARD_DEVIATION 1.7 • n=7 Participants
|
9.6 percent
STANDARD_DEVIATION 1.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsChange from baseline in HbA1c or glycosylated hemoglobin (%)
Outcome measures
| Measure |
Integrated Behavioral Intervention
n=67 Participants
Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.
Integrated Behavioral Care: Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.
|
Usual Care
n=72 Participants
Patients receive usual care
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (%)
|
-0.92 change from baseline in A1c (%)
Standard Deviation 1.8
|
-0.31 change from baseline in A1c (%)
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsDiabetes regimen-related distress is a measure of the emotional response to having and managing diabetes and is measured by a subscale of 5 items (#5, 6, 10, 12, 16) from the Diabetes-related Distress instrument (DDS-17). Each item is rated from 1 (not a problem) - 6 (very serious problem) and therefore the total score for this sub-score ranges from 5 - 30. The mean score for an individual can be computed as the sum of the 5 items divided by 5. For this study outcome, the investigators computed the average change (increase or decrease) in the mean RRD score from baseline to 12-mo. follow-up.
Outcome measures
| Measure |
Integrated Behavioral Intervention
n=67 Participants
Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.
Integrated Behavioral Care: Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.
|
Usual Care
n=72 Participants
Patients receive usual care
|
|---|---|---|
|
Change From Baseline in Diabetes Regimen-Related Distress
|
-1.1 score on a scale
Standard Deviation 1.0
|
-0.3 score on a scale
Standard Deviation 1.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 12 monthsDiabetes self-care activities as measured by the Self-reported Diabetes Self Care Activities (SDSCA) instrument. The SDSCA is a questionnaire which assesses levels of self-care in adults with diabetes. The tool contains 11 items, which measure the frequency of performing diabetes self-care activities over the last seven days including diet, exercise, blood glucose testing, foot care and tobacco use. The respondent marks the number of days on which the indicated behavior was performed on an eight-point Likert scale (0 - 7) to answer the questions. The first ten items are summed to a total score. The eleventh item focuses on smoking habits and assesses the average number of cigarettes smoked per day. For the present study, the total score was summed and divided by 11 items to create a mean score and then the average change from baseline to 12 month follow-up.
Outcome measures
| Measure |
Integrated Behavioral Intervention
n=67 Participants
Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.
Integrated Behavioral Care: Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.
|
Usual Care
n=72 Participants
Patients receive usual care
|
|---|---|---|
|
Change in Diabetes Self-care Activities
|
1.1 score on a scale
Standard Deviation 1.3
|
0.58 score on a scale
Standard Deviation 1.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 12 monthsChange in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) instrument for depressive symptoms. Diagnosis based on Total PHQ-9 Score; Interpretation: Minimal depression 0-4 Mild depression 5-9 Moderate depression 10-14 Moderately severe depression 15-19 Severe depression 20-27
Outcome measures
| Measure |
Integrated Behavioral Intervention
n=67 Participants
Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.
Integrated Behavioral Care: Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.
|
Usual Care
n=72 Participants
Patients receive usual care
|
|---|---|---|
|
Change in Depressive Symptoms
|
-3.4 score on a scale
Standard Deviation 5.0
|
-0.9 score on a scale
Standard Deviation 6.2
|
Adverse Events
Integrated Behavioral Intervention
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place