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Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression

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ClinicalTrials.gov Identifier: NCT01572389
Recruitment Status : Completed
First Posted : April 6, 2012
Results First Posted : November 1, 2017
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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
Enrollment 225
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Arm 1: HOPE Arm 2: EUC
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 136 89
Completed 90 68
Not Completed 46 21
Reason Not Completed
Death             1             3
Withdrawal by Subject             14             2
Lost to Follow-up             25             14
Only A1C or Assessment was Collected             6             2
Arm/Group Title Arm 1: HOPE Arm 2: EUC Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 136 89 225
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 136 participants 89 participants 225 participants
62.6  (8.4) 60.8  (8.0) 61.9  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 89 participants 225 participants
Female
15
  11.0%
8
   9.0%
23
  10.2%
Male
121
  89.0%
81
  91.0%
202
  89.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 136 participants 89 participants 225 participants
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%
1.Primary Outcome
Title Change in Hemoglobin A1C
Hide Description Measures of Hemoglobin A1C will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control. Hemoglobin A1C is a blood test taken to assess average blood glucose levels in the body. Normal range of A1C level is below 5.7. Eligible participants had an A1C of 7.5 or higher. The higher the A1C the more a person's diabetes is uncontrolled.
Time Frame Hemoglobin A1C levels will be measured at baseline, 6-, and 12- months.
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed at each timepoint decreased due to non-completion of the A1C blood draw by participants.
Arm/Group Title Arm 1: HOPE Arm 2: EUC
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 136 89
Mean (Standard Deviation)
Unit of Measure: percentage of glycated hemoglobin
Baseline Number Analyzed 136 participants 89 participants
9.2  (1.4) 9.3  (1.5)
6-Months Number Analyzed 105 participants 78 participants
9.1  (1.7) 8.7  (1.7)
12-Months Number Analyzed 90 participants 68 participants
8.7  (1.6) 8.9  (2)
2.Primary Outcome
Title Change in Patient Health Questionnaires-9 During Intervention
Hide Description The Patient Health Questionnaires-9 assesses depressive symptoms during the course of the intervention. The PHQ-9 ranges in score from 0 - 27; where higher numbers represent increase levels of depression. Scores from 5 - 9 represent "minimal symptoms" of depression; 10 - 14 represent "minor depression", dysthymia, or major depression - mild; 15 - 19 represent "major depression, moderately severe"; and scores of 20 and above is considered "major depression, severe." Participants with that scored a 10 or above were eligible for the study.
Time Frame PHQ-9 will be assessed at baseline, 6-, and 12- months.
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed at each timepoint decreased due to non-completion of the assessment by participants.
Arm/Group Title Arm 1: HOPE Arm 2: EUC
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 136 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline Number Analyzed 136 participants 89 participants
15.8  (4.2) 16.2  (4)
6 Months Number Analyzed 105 participants 78 participants
10.9  (6.1) 12.4  (6)
12 Months Number Analyzed 90 participants 68 participants
10.1  (6.9) 12.6  (6.5)
Time Frame Adverse event data were collected at 6 and 12 months at the time of assessments.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: HOPE Arm 2: EUC
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Arm 1: HOPE Arm 2: EUC
Affected / at Risk (%) Affected / at Risk (%)
Total   1/136 (0.74%)      3/89 (3.37%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: HOPE Arm 2: EUC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/136 (0.74%)      0/89 (0.00%)    
Infections and infestations     
Foot Sore * [1]  1/136 (0.74%)  1 0/89 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Patient indicated to his coach he had a sore on his foot that would not heal. He followed up with his physician and there was concern about the length of time it was taking to heal. There was no indication the sore was due to his participation.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: HOPE Arm 2: EUC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/136 (0.00%)      0/89 (0.00%)    
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
Layout table for Results Point of Contact information
Name/Title: Aanand, Naik, MD
Organization: Department of Veteran Affairs
Phone: 713-794-8541
EMail: anaik@bcm.edu
Layout table for additonal information
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