HOPE Pilot for Veterans With Complex Diabetes

United States Department of Veterans Affairs

Status: Completed

Conditions: Diabetes; Depression

Treatments: Behavioral: Behavioral Health Coaching

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01274715

VA ID 10G09.H

Details and patient eligibility

About

The purpose of this study is to determine if behavioral health coaching for rural veterans with diabetes and depression will improve self-management behaviors and lead to improvement in diabetes care outcomes (e.g., HA1C) and improvement in reported depressive symptoms.

Full description

The co-occurence of diabetes and depression is highly prevalent and has dramatic consequences for quality of life and health. Due to the complex interrelation between diabetes and depression, patients often experience both psychological and physiological difficulties. These comorbid problems demand focused interventions that blend physical and emotional health treatments with self-management strategies.Rural-dwelling veterans with diabetes and depression are typically treated in community-based outpatient clinics (CBOCs). Patients with diabetes in rural areas tend to have more problems controlling their blood sugar, blood pressure and cholesterol compared to urban patients; thereby increasing their risk of diabetic complications. Similarly, rural patients with depression have similar barriers to care that increase their risk of poorer health outcomes as well. Using behavioral health coaches (BHCs)to deliver telephone-mediated therapies may enhance the reach of treatments for co-occurring diabetes and depression. The implementation of such treatments requires the development and testing of therapeutic manuals and BHC training protocols to ensure standardization and effectiveness. The BHC intervention has been labeled Health Outcomes through Patient Empowerment (HOPE) and will be offered to eligible patients receiving care through MEDVAMC and its CBOCs. Preliminary data obtained through this pilot grant is to support a larger VA grant.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of type 2 diabetes and Primary Care Physician intent to treat
• Clinically significant symptoms of depression per self-report
• HA1C average of 7.5 or greater in past 12 months AND no HA1C < 7.0 in past 12 months.

Exclusion criteria

• Factors that render a telephone-based behavioral activation intervention inappropriate
• Significant cognitive impairment
• Meet criteria of bipolar, psychotic or substance abuse disorder
• Serious medical issues; e.g., terminal cancer
• Reports severe depression or suicidal ideation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Behavioral Health Coaching arm

Experimental group

Description:

This is a single-arm, pilot study of a health behavior coaching intervention to consist of 12 sessions of coaching over a 3 month period. There is no control arm for this pilot study.

Treatment:

Behavioral: Behavioral Health Coaching