HOPE Pilot for Veterans With Complex Diabetes (HOPE)
|ClinicalTrials.gov Identifier: NCT01274715|
Recruitment Status : Completed
First Posted : January 11, 2011
Results First Posted : May 8, 2014
Last Update Posted : May 8, 2014
|Condition or disease||Intervention/treatment|
|Diabetes Depression||Behavioral: Behavioral Health Coaching|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Behavioral Health Coaching for Rural Veterans With Diabetes and Depression|
|Study Start Date :||January 2011|
|Primary Completion Date :||July 2011|
|Study Completion Date :||July 2011|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274715
|United States, Texas|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Aanand D Naik, MD||Michael Debakey Veterans Affairs Medical Center|
|Principal Investigator:||Jeffrey A Cully, PhD||Michael Debakey Veterans Affairs Medical Center|