HOPE Pilot for Veterans With Complex Diabetes
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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.
Condition | Intervention |
---|---|
Diabetes Depression |
Behavioral: behavioral health coaching |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Behavioral Health Coaching for Rural Veterans With Diabetes and Depression |
- Change in PHQ-9 scores, and change in HbA1c levels [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]The coaching sessions take place over approximately 3 months -- outcomes are measured at 3 months and again at 6 months.
Estimated Enrollment: | 20 |
Study Start Date: | January 2011 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
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Behavioral: behavioral health coaching
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 effictiveness. 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of type 2 diabetes and PCP 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
Contact: Aanand D Naik, MD | 713-794-8601 | anaik@bcm.edu |
Contact: Jeffrey A Cully, PhD | 713-794-8601 | jcully@bcm.edu |
United States, Texas | |
MEDVAMC | Not yet recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Aanand D Naik, MD | |
Principal Investigator: Jeffrey A Cully, PhD |
Principal Investigator: | Aanand D Naik, MD | Michael Debakey Veterans Affairs Medical Center |
Principal Investigator: | Jeffrey A Cully, PhD | Michael Debakey Veterans Affairs Medical Center |
No publications provided
Responsible Party: | Aanand Naik, MD / Principal Investigator, MDVAMC |
ClinicalTrials.gov Identifier: | NCT01274715 History of Changes |
Other Study ID Numbers: | VA ID 10G09.H |
Study First Received: | January 10, 2011 |
Last Updated: | January 10, 2011 |
Health Authority: | United States: Michael Debakey Veterans Affairs Medical Center |
Keywords provided by Michael Debakey Veterans Affairs Medical Center:
Behavioral health coaching Diabetes Emotional health |
Additional relevant MeSH terms:
Depression Depressive Disorder Diabetes Mellitus Behavioral Symptoms Mood Disorders |
Mental Disorders Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on October 18, 2012