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NCT01572389 · ClinicalTrials.gov registry record · NA
Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 225
- Enrollment target
NCT01572389: Completed NA study, sponsored by VA Office of Research and Development.
NCT01572389 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 225 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01572389, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 225 participants
- Enrollment target
Study Summary
This clinical trial will compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) for diabetes and depression at 6 and 12 month follow-up. The proposed study is a randomized controlled trial enrolling 242 largely rural Veterans with uncontrolled diabetes and clinically-significant depressive symptoms. Both groups will receive screening, education, and notification of clinical findings along with follow-up in usual primary care. HOPE participants will also receive behavioral coaching telephone sessions over a six month period. Patients in the control group will be screened, and providers will be notified of high risk patients' status and need for intervention. Both groups will receive only usual primary care during the subsequent 6 month maintenance period. Study measurements using self-report questionnaires will also be collected at baseline, 6 and 12 months follow-up. The investigators will also conduct chart reviews to evaluate usual care blood tests for diabetes control. Changes in measurements from baseline will be compared between groups. This intervention will reach Veterans in rural setting where community-based primary care is needed, especially care that blends treatment strategies for physical and emotional health.
Primary Outcome
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.
Interventions
- BEHAVIORAL Enhanced Usual Care
- BEHAVIORAL Healthy Outcomes through Patient Empowerment (HOPE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2012-11-01 |
| Est. Completion | 2016-09-30 |
| Phase | NA |
What the finished NCT01572389 record still lists
NCT01572389 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Enhanced Usual Care is the first listed.
NCT01572389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01572389 about?
NCT01572389 is a clinical study titled "Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression". This clinical trial will compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) for diabetes and depression at 6 and 12 month follow-up. The proposed study is a randomized controlled trial enrolling 242 largely rural Veterans wi...
What is the current status of trial NCT01572389?
This trial is currently completed. It is a NA study. The enrollment target is 225 participants. The study started on 2012-11-01. Estimated completion is 2016-09-30.
What interventions are being tested in trial NCT01572389?
The interventions under investigation include: Enhanced Usual Care (BEHAVIORAL), Healthy Outcomes through Patient Empowerment (HOPE) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01572389?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01572389's enrollment target sits among peer trials
225 472nd of 2000 higher than 1,523 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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