HOPE Pilot for Veterans With Complex Diabetes (HOPE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|