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Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01572389
First Posted: April 6, 2012
Last Update Posted: November 1, 2017
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.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: June 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions: Diabetes Mellitus
Depression
Interventions: Behavioral: Healthy Outcomes through Patient Empowerment (HOPE)
Behavioral: Enhanced Usual Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were a total of 225 participants enrolled into the study. Consent occurred at baseline and participants were eligible if they scored a 10 or greater on the PHQ-9 and an A1C of 7.5 or greater. If a participant didn't meet these criteria then they were not randomized into the study.

Reporting Groups
  Description
Arm 1: HOPE

The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals.

Healthy Outcomes through Patient Empowerment (HOPE): HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period.

Arm 2: EUC

The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions.

Enhanced Usual Care: All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care.


Participant Flow:   Overall Study
    Arm 1: HOPE   Arm 2: EUC
STARTED   136   89 
COMPLETED   90   68 
NOT COMPLETED   46   21 
Death                1                3 
Withdrawal by Subject                14                2 
Lost to Follow-up                25                14 
Only A1C or Assessment was Collected                6                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1: HOPE

The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals.

Healthy Outcomes through Patient Empowerment (HOPE): HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period.

Arm 2: EUC

The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions.

Enhanced Usual Care: All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care.

Total Total of all reporting groups

Baseline Measures
   Arm 1: HOPE   Arm 2: EUC   Total 
Overall Participants Analyzed 
[Units: Participants]
 136   89   225 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.6  (8.4)   60.8  (8.0)   61.9  (8.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      15  11.0%      8   9.0%      23  10.2% 
Male      121  89.0%      81  91.0%      202  89.8% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race       
White      73  53.7%      51  57.3%      124  55.1% 
Black      41  30.1%      16  18.0%      57  25.3% 
Hispanic      12   8.8%      11  12.4%      23  10.2% 
Other      2   1.5%      4   4.5%      6   2.7% 
More than 1 race      8   5.9%      7   7.9%      15   6.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Hemoglobin A1C   [ Time Frame: Hemoglobin A1C levels will be measured at baseline, 6-, and 12- months. ]

2.  Primary:   Change in Patient Health Questionnaires-9 During Intervention   [ Time Frame: PHQ-9 will be assessed at baseline, 6-, and 12- months. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Aanand, Naik, MD
Organization: Department of Veteran Affairs
phone: 713-794-8541
e-mail: anaik@bcm.edu


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01572389     History of Changes
Other Study ID Numbers: IIR 10-135
First Submitted: March 7, 2012
First Posted: April 6, 2012
Results First Submitted: June 14, 2017
Results First Posted: November 1, 2017
Last Update Posted: November 1, 2017