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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01572389
The ClinicalTrials.gov registry entry for NCT01572389 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Enhanced Usual Care is the first listed.
NCT01572389 reports 0 study locations.
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.
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