HOPE Pilot for Veterans With Complex Diabetes

This study has been completed.
Sponsor:
Collaborator:
South Central VA Mental Illness Research, Education & Clinical Center
Information provided by (Responsible Party):
Aanand Naik, Michael Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01274715
First received: January 10, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Michael Debakey Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Change in PHQ-9 (Patient Health Questionnaire-9)Scores [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    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.

  • Change in Hemoglobin A1C [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: January 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274715

Locations
United States, Texas
MEDVAMC
Houston, Texas, United States, 77030
Sponsors and Collaborators
Michael Debakey Veterans Affairs Medical Center
South Central VA Mental Illness Research, Education & Clinical Center
Investigators
Principal Investigator: Aanand D Naik, MD Michael Debakey Veterans Affairs Medical Center
Principal Investigator: Jeffrey A Cully, PhD Michael Debakey Veterans Affairs Medical Center
  More Information

Publications:
Responsible Party: Aanand Naik, Assistant Professor of Medicine, Michael Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01274715     History of Changes
Other Study ID Numbers: VA ID 10G09.H
Study First Received: January 10, 2011
Results First Received: October 25, 2012
Last Updated: April 7, 2014
Health Authority: United States: Federal Government

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 July 20, 2014