Trial Outcomes & Findings for Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression (NCT NCT01572389)
NCT ID: NCT01572389
Last Updated: 2017-11-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
225 participants
Primary outcome timeframe
Hemoglobin A1C levels will be measured at baseline, 6-, and 12- months.
Results posted on
2017-11-01
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
136
|
89
|
|
Overall Study
COMPLETED
|
90
|
68
|
|
Overall Study
NOT COMPLETED
|
46
|
21
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Death
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
14
|
2
|
|
Overall Study
Lost to Follow-up
|
25
|
14
|
|
Overall Study
Only A1C or Assessment was Collected
|
6
|
2
|
Baseline Characteristics
Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression
Baseline characteristics by cohort
| Measure |
Arm 1: HOPE
n=136 Participants
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
n=89 Participants
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
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
61.9 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
73 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
41 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · More than 1 race
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Hemoglobin A1C levels will be measured at baseline, 6-, and 12- months.Population: The number analyzed at each timepoint decreased due to non-completion of the A1C blood draw by participants.
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.
Outcome measures
| Measure |
Arm 1: HOPE
n=136 Participants
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
n=89 Participants
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.
|
|---|---|---|
|
Change in Hemoglobin A1C
6-Months
|
9.1 percentage of glycated hemoglobin
Standard Deviation 1.7
|
8.7 percentage of glycated hemoglobin
Standard Deviation 1.7
|
|
Change in Hemoglobin A1C
12-Months
|
8.7 percentage of glycated hemoglobin
Standard Deviation 1.6
|
8.9 percentage of glycated hemoglobin
Standard Deviation 2
|
|
Change in Hemoglobin A1C
Baseline
|
9.2 percentage of glycated hemoglobin
Standard Deviation 1.4
|
9.3 percentage of glycated hemoglobin
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: PHQ-9 will be assessed at baseline, 6-, and 12- months.Population: The number analyzed at each timepoint decreased due to non-completion of the assessment by participants.
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.
Outcome measures
| Measure |
Arm 1: HOPE
n=136 Participants
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
n=89 Participants
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.
|
|---|---|---|
|
Change in Patient Health Questionnaires-9 During Intervention
baseline
|
15.8 units on a scale
Standard Deviation 4.2
|
16.2 units on a scale
Standard Deviation 4
|
|
Change in Patient Health Questionnaires-9 During Intervention
6 Months
|
10.9 units on a scale
Standard Deviation 6.1
|
12.4 units on a scale
Standard Deviation 6
|
|
Change in Patient Health Questionnaires-9 During Intervention
12 Months
|
10.1 units on a scale
Standard Deviation 6.9
|
12.6 units on a scale
Standard Deviation 6.5
|
Adverse Events
Arm 1: HOPE
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Arm 2: EUC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Arm 1: HOPE
n=136 participants at risk
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
n=89 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Foot Sore
|
0.74%
1/136 • Number of events 1 • Adverse event data were collected at 6 and 12 months at the time of assessments.
|
0.00%
0/89 • Adverse event data were collected at 6 and 12 months at the time of assessments.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place