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

University of North Carolina System

Status: Completed

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

Treatments: Behavioral: Integrated Behavioral Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02863523

COMRADE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 139 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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139 participants in 2 patient groups

Integrated Behavioral Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Integrated Behavioral Care

Usual Care

No Intervention group

Description:

Patients receive usual care