NCT02863523

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: East Carolina University · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus
• Diabetes-related Distress
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-08-11
• Last updated: 2023-12-08
• Results posted: 2023-12-08

Locations

1 site across 1 country: United States