HOPE Pilot for Veterans With Complex Diabetes

Depression Clinical Trial

— HOPE  

Official title:

Behavioral Health Coaching for Rural Veterans With Diabetes and Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01274715
• Other study ID #: VA ID 10G09.H
• Status: Completed
• Phase: N/A
• First received: January 10, 2011
• Last updated: April 7, 2014
• Start date: January 2011
• Est. completion date: July 2011

Study information

• Verified date: April 2014
• Source: Michael Debakey Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Diabetes

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	MEDVAMC	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Michael Debakey Veterans Affairs Medical Center	South Central VA Mental Illness Research, Education & Clinical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PHQ-9 (Patient Health Questionnaire-9)Scores	The full name of the measure is the Patient Health Questionnaire-9. This is a self-reported measure of depressive symptoms. This is a nine item measure with a response for each item between 0-3. Total scores on this measure range from 0-27, with 0 being a minimum indicating no depressive symptoms, and 27 being the maximum number and severity of depressive symptoms. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.	Baseline, 3 months, and 6 months	No
Primary	Change in Hemoglobin A1C	Value of Hemoglobin A1C reduction post-intervention. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.	baseline, 3 months, and 6 months	No