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

Not Applicable

Completed

• Conditions: Diabetes-related Distress; Depression; Type 2 Diabetes Mellitus

• Registration Number: NCT02863523
• Lead Sponsor: East Carolina University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-11
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Results First Submitted: 2019-02-14
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-10
• Last Update Submitted: 2023-03-10
• Results First Posted: 2023-12-08
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

1. Clinical Diagnosis of Type 2 diabetes mellitus
2. Glycosylated Hemoglobin (HbA1c) > 7.0 = Uncontrolled
3. Positive score on diabetes related distress 2 question screener and/or
4. 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:

1. 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
2. alcoholism or
3. cognitive impairment, or
4. major psychiatric disease or
5. any type of physical or mental impairment that would preclude active participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Hemoglobin (%)	Baseline to 12 months	Change from baseline in HbA1c or glycosylated hemoglobin (%)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Diabetes Regimen-Related Distress	Baseline to 12 months	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.

Trial Locations

Locations (1)

East Carolina University; 🇺🇸 Greenville, North Carolina, United States