HOPE Pilot for Veterans With Complex Diabetes

NCT ID: NCT01274715

Last Updated: 2014-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-07-31

Brief Summary

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.

Detailed 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.

Conditions

Diabetes; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Behavioral Health Coaching arm

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.

Group Type: EXPERIMENTAL

Behavioral Health Coaching

Intervention Type: BEHAVIORAL

Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.

Interventions

Behavioral Health Coaching

Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Central VA Mental Illness Research, Education & Clinical Center

FED

Sponsor Role: collaborator

Michael E. DeBakey VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Aanand Naik

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aanand D Naik, MD

Role: PRINCIPAL_INVESTIGATOR

Michael E. DeBakey VA Medical Center

Jeffrey A Cully, PhD

Role: PRINCIPAL_INVESTIGATOR

Michael E. DeBakey VA Medical Center

Locations

MEDVAMC

Houston, Texas, United States

Countries

United States

References

Naik AD, White CD, Robertson SM, Armento ME, Lawrence B, Stelljes LA, Cully JA. Behavioral health coaching for rural-living older adults with diabetes and depression: an open pilot of the HOPE Study. BMC Geriatr. 2012 Jul 24;12:37. doi: 10.1186/1471-2318-12-37.

Reference Type: RESULT

PMID: 22828177 (View on PubMed)

Other Identifiers

VA ID 10G09.H

Identifier Type: -

Identifier Source: org_study_id