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NCT05423158 · ClinicalTrials.gov registry record · Phase 2
Virtual Care Strategies to Improve Participation in Cardiac Rehabilitation Among Veterans
A Phase 2 study of Cardiovascular Diseases, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 2
- Study locations
NCT05423158 is a Phase 2 study of Cardiovascular Diseases that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 150 participants, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05423158, a Phase 2 study of Cardiovascular Diseases, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 2
- Study locations
Study Summary
Home-based CR (HBCR) is an alternative to traditional CR programs that has comparable efficacy in improving morbidity/mortality and increases access to critical services. There is major potential to improve Veteran engagement in CR by combining digital coaching (d-Coaching) with existing VA-supported technologies. The investigator's theory-based intervention targets a critical component of successful CR engagement that is not available through traditional programs: virtual social support through a social network. In addition, the investigators propose to improve self-efficacy and self-regulation through interactive digital multi-media education, personalized feedback, and motivation so that Veterans can complete the prescribed HBCR program and maintain physical activity long-term. This RCT will evaluate the effects of HBCR alone (usual care) versus HBCR + d-Coaching, including a private group with direct messaging on the Connecteam mobile application and bimonthly engagement sessions via VA Video Connect. The investigators will randomly assign 150 Veterans from 2 HBCR programs to a 3-month intervention. The addition of d- Coaching to existing digital technologies will be operationalized by using a private social media group to provide social support, education, personalized feedback, and motivation. The investigators aim to determine the effect of the d-Coaching intervention on: a) the number of completed HBCR sessions over 3 months, b) functional capacity, c) physical activity, c) psychosocial outcomes, d) clinical outcomes, and e) social cognitive factors of self-efficacy, self-regulation, and perceived social support over 6 months. The investigators will also evaluate the extent to which self-efficacy, self-regulation, and perceived social support mediate the effect of the intervention on function and physical activity.
Conditions Studied
Interventions
- BEHAVIORAL d-Coaching
Study Locations (2)
California
- San Francisco VA Medical Center, San Francisco, CA - San Francisco
Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA - Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-03-15 |
| Est. Completion | 2026-02-28 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05423158
The ClinicalTrials.gov registry entry for NCT05423158 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% 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 1 condition, with Cardiovascular Diseases appearing as the primary indexed condition, and to 1 intervention - of which d-Coaching is the first listed.
NCT05423158 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Georgia.
Frequently Asked Questions
What is clinical trial NCT05423158 about?
NCT05423158 is a clinical study titled "Virtual Care Strategies to Improve Participation in Cardiac Rehabilitation Among Veterans". Home-based CR (HBCR) is an alternative to traditional CR programs that has comparable efficacy in improving morbidity/mortality and increases access to critical services. There is major potential to improve Veteran engagement in CR by combining digital coaching (d-Coaching) with existing VA-supporte...
What is the current status of trial NCT05423158?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2023-03-15. Estimated completion is 2026-02-28.
What conditions does trial NCT05423158 study?
This clinical trial studies the following conditions: Cardiovascular Diseases.
What interventions are being tested in trial NCT05423158?
The interventions under investigation include: d-Coaching (BEHAVIORAL).
Who is sponsoring clinical trial NCT05423158?
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 NCT05423158 being conducted?
This trial has 2 study locations across California, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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