HOPE Pilot for Veterans With Complex Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Michael Debakey Veterans Affairs Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
South Central VA Mental Illness Research, Education & Clinical Center
Information provided by:
Michael Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01274715
First received: January 10, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  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 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)
Intervention Details:
    Behavioral: behavioral health coaching
    Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cogntive 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 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.

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

Contacts
Contact: Aanand D Naik, MD 713-794-8601 anaik@bcm.edu
Contact: Jeffrey A Cully, PhD 713-794-8601 jcully@bcm.edu

Locations
United States, Texas
MEDVAMC Not yet recruiting
Houston, Texas, United States, 77030
Principal Investigator: Aanand D Naik, MD         
Principal Investigator: Jeffrey A Cully, PhD         
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

No publications provided by Michael Debakey Veterans Affairs Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 April 15, 2014