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HOPE Pilot for Veterans With Complex Diabetes (HOPE)

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ClinicalTrials.gov Identifier: NCT01274715
Recruitment Status : Completed
First Posted : January 11, 2011
Results First Posted : May 8, 2014
Last Update Posted : May 8, 2014
Sponsor:
Collaborator:
South Central VA Mental Illness Research, Education & Clinical Center
Information provided by (Responsible Party):
Aanand Naik, Michael Debakey Veterans Affairs Medical Center

Tracking Information
First Submitted Date  ICMJE January 10, 2011
First Posted Date  ICMJE January 11, 2011
Results First Submitted Date  ICMJE October 25, 2012
Results First Posted Date  ICMJE May 8, 2014
Last Update Posted Date May 8, 2014
Study Start Date  ICMJE January 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2014)
  • Change in PHQ-9 (Patient Health Questionnaire-9)Scores [ Time Frame: Baseline, 3 months, and 6 months ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 10, 2011)
Change in PHQ-9 scores, and change in HbA1c levels [ Time Frame: 3-6 months ]
The coaching sessions take place over approximately 3 months -- outcomes are measured at 3 months and again at 6 months.
Change History Complete list of historical versions of study NCT01274715 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HOPE Pilot for Veterans With Complex Diabetes
Official Title  ICMJE Behavioral Health Coaching for Rural Veterans With Diabetes and Depression
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Depression
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Behavioral Health Coaching
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2014)
12
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2011)
20
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01274715
Other Study ID Numbers  ICMJE VA ID 10G09.H
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aanand Naik, Michael Debakey Veterans Affairs Medical Center
Study Sponsor  ICMJE Michael Debakey Veterans Affairs Medical Center
Collaborators  ICMJE South Central VA Mental Illness Research, Education & Clinical Center
Investigators  ICMJE
Principal Investigator: Aanand D Naik, MD Michael Debakey Veterans Affairs Medical Center
Principal Investigator: Jeffrey A Cully, PhD Michael Debakey Veterans Affairs Medical Center
PRS Account Michael Debakey Veterans Affairs Medical Center
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP