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Trial record 14 of 1594 for:    veterans affairs medical center

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
Sponsor:
Collaborator:
South Central VA Mental Illness Research, Education & Clinical Center
Information provided by (Responsible Party):
Aanand Naik, Michael Debakey Veterans Affairs Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes
Depression
Intervention Behavioral: Behavioral Health Coaching
Enrollment 12
Recruitment Details The recruitment period lasted from January 2011 through July 2011. After patients were screened, recruitment occurred over the phone, where they gave audio consent to participate in the study.
Pre-assignment Details Three participants who gave consent to participate in the study met exclusion criteria at baseline and were removed from the study before being assigned to the intervention.
Arm/Group Title Behavioral Health Coaching
Hide Arm/Group Description Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
Period Title: Overall Study
Started 12
Screened Out at Baseline 3
Completed 8
Not Completed 4
Reason Not Completed
Lost to Follow-up             1
After consent, met exclusion criteria.             1
After consent, met exclusion criteria.             1
After consent, met exclusion criteria.             1
Arm/Group Title Behavioral Health Coaching
Hide Arm/Group Description Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
  83.3%
>=65 years
2
  16.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
61.4  (5.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
3
  25.0%
Male
9
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Change in PHQ-9 (Patient Health Questionnaire-9)Scores
Hide Description 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.
Time Frame Baseline, 3 months, and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Health Coaching
Hide Arm/Group Description:
Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Change from baseline to 3-month, M (SD) 5.14  (2.27)
Change from baseline to 6-month, M (SD) 7.03  (4.43)
2.Primary Outcome
Title Change in Hemoglobin A1C
Hide Description 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.
Time Frame baseline, 3 months, and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Health Coaching
Hide Arm/Group Description:
Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: percentage of glycated hemoglobin
Change from baseline to 3 months 1.13  (1.7)
Change from baseline to 6 months 0.84  (1.62)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Behavioral Health Coaching
Hide Arm/Group Description Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
All-Cause Mortality
Behavioral Health Coaching
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Behavioral Health Coaching
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Behavioral Health Coaching
Affected / at Risk (%)
Total   0/8 (0.00%) 
A very small sample was collected, and there was not a control group to compare to our intervention group.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Aanand Naik, MD
Organization: Michael DeBakey VAMC
Phone: 713-794-8541
EMail: anaik@bcm.edu
Layout table for additonal information
Responsible Party: Aanand Naik, Michael Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01274715     History of Changes
Other Study ID Numbers: VA ID 10G09.H
First Submitted: January 10, 2011
First Posted: January 11, 2011
Results First Submitted: October 25, 2012
Results First Posted: May 8, 2014
Last Update Posted: May 8, 2014