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NCT04877197 · ClinicalTrials.gov registry record · Phase 3
Behavioral Activation Delivered Via Home-based Telehealth to Improve Functioning in Cardiovascular Disease Patients Recently Discharged From Inpatient Care
A Phase 3 study of Depression and Cardiovascular Diseases, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 132
- Enrollment target
- 1
- Study location
NCT04877197 is a Phase 3 study of Depression and Cardiovascular Diseases that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 132 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04877197, a Phase 3 study of Depression and Cardiovascular Diseases, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 132 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to demonstrate whether Behavioral Activation for depression delivered via home based telehealth (BA-HT) is effective in improving social and role functioning in Veterans recently discharged from Cardiovascular disease (CVD-related) inpatient care. Eligible participants will receive either (1) twelve sessions of BA-HT or (2) standard best practices post CVD hospitalization care. Study participants will be 132 Veterans discharged from the Ralph H. Johnson VA Medical Center inpatient care facilities with CVD diagnoses corresponding to ICD 10 codes I20-I25 (120 unstable angina, stable angina; 121 NSTEMI, STEMI, initial encounter; 122 NSTEMI, STEMI, subsequent encounter; 124 acute coronary syndrome; 125 coronary arteriosclerosis with angina). They will be male or female, age 21 and above, and with approximately 40-50% minority representation. There will be assessment at baseline, 1 week post treatment, as well as 3 and 9-months post treatment. The investigators predict that BA-HT will more effectively increase social role and activity functioning, activity, mood and reduce 9-month re-hospitalization compared to current best-practices post-discharge care among patients scoring at least moderately depressed on the PROMIS Depression scale one week following hospital discharge for a CVD event.
Conditions Studied
Interventions
- BEHAVIORAL BA-HT
- OTHER Standard Care
Study Locations (1)
South Carolina
- Ralph H. Johnson VA Medical Center, Charleston, SC - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2022-01-17 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04877197
The ClinicalTrials.gov registry entry for NCT04877197 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (83% lower). 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 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which BA-HT is the first listed.
NCT04877197 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.
Frequently Asked Questions
What is clinical trial NCT04877197 about?
NCT04877197 is a clinical study titled "Behavioral Activation Delivered Via Home-based Telehealth to Improve Functioning in Cardiovascular Disease Patients Recently Discharged From Inpatient Care". The purpose of this study is to demonstrate whether Behavioral Activation for depression delivered via home based telehealth (BA-HT) is effective in improving social and role functioning in Veterans recently discharged from Cardiovascular disease (CVD-related) inpatient care. Eligible participants w...
What is the current status of trial NCT04877197?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 132 participants. The study started on 2022-01-17. Estimated completion is 2026-09-30.
What conditions does trial NCT04877197 study?
This clinical trial studies the following conditions: Depression, Cardiovascular Diseases.
What interventions are being tested in trial NCT04877197?
The interventions under investigation include: BA-HT (BEHAVIORAL), Standard Care (OTHER).
Who is sponsoring clinical trial NCT04877197?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04877197 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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