COMRADE: Collaborative Care Management for Distress and Depression in Rural Diabetes

Study Overview
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Brief Summary
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The study will implement and evaluate, using a pragmatic comparative effectiveness trial, a unique collaborative, stepped-care intervention for patients with uncontrolled Type 2 diabetes and co-morbid distress and/or depression.

Detailed Description
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The investigators plan to implement and evaluate, using a pragmatic comparative effectiveness trial, a unique collaborative, stepped-care intervention for patients with uncontrolled Type 2 diabetes and co-morbid distress and/or depression. The investigators approach will combine practice-based medical and cognitive behavioral treatment with strong community-based support to immediately place the patient at the right level of intervention based on disease and severity and to step-up treatment intensity and follow-up if the initial response is inadequate. The practice-based component will use a care manager linked to medical, pharmacologic, and behavioral colleagues. The community based component will utilize community health workers to provide support and facilitate access to resources. Goals include: 1) implementing and evaluating the effectiveness of this intervention; 2) examining the impact of this approach on psychological mediators of improved glycosylated hemoglobin (HbA1c); and 3) building, sustaining, and disseminating a cost-effective care model.

Official Title
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COMRADE: Collaborative Care Management for Distress and Depression in Rural Diabetes

Conditions
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Type 2 Diabetes Mellitus, Diabetes-related Distress, Depression

Intervention / Treatment
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* Behavioral: Integrated Behavioral Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical Diagnosis of Type 2 diabetes mellitus Glycosylated Hemoglobin (HbA1c) > 7.0 = Uncontrolled Positive score on diabetes related distress 2 question screener and/or Positive score on Patient Health Questionnaire (PHQ-2) 2 question screener Exclusion Criteria: a diagnosis [from billing records using International Classification of Disease, 9th Edition (ICD-9) codes] of: advanced disease (e.g., end stage renal disease, advanced heart failure, blindness, metastatic cancer and including those who are in active treatment for cancer), or alcoholism or cognitive impairment, or major psychiatric disease or any type of physical or mental impairment that would preclude active participation

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated Behavioral Intervention<br>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. | Behavioral: Integrated Behavioral Care<br>* 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.<br>|
| No Intervention: Usual Care<br>Patients receive usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Glycosylated Hemoglobin (%) | Change from baseline in HbA1c or glycosylated hemoglobin (%) | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Diabetes Regimen-Related Distress | Diabetes 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. | Baseline to 12 months |