Recruiting

Virtual Care

Sponsor:

VA Office of Research and Development

Code:

NCT05423158

Conditions

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

d-Coaching

Study Details

Brief 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

Cardiovascular Diseases

Study ID

NCT05423158

Start date

Mar 15, 2023

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. History of cardiovascular disease that qualified participant for CR (MI, percutaneous coronary intervention, coronary artery bypass grafting, heart failure, valve surgery)
2. Referral to participate in home-based Phase II CR

Exclusion Criteria:

1. Participation in center-based Phase II CR
2. Cognitive impairment (per Mini-Cog)
3. Lack of English proficiency/literacy (Digital coaching will be conducted in English. Participants will need to speak/read English to receive intervention.)
4. Unstable clinical conditions (e.g., unstable arrhythmias or heart block, active infection, uncontrolled hypertension, decompensated heart failure, unstable angina, etc.)

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: d-Coaching

Will receive home-based cardiac rehabilitation (HBCR) with digital coaching (d-Coaching) intervention

no intervention: Usual Care

Will receive home-based cardiac rehabilitation (HBCR) alone

Interventions

d-Coaching

MOVN mobile app: Each participant will be assigned a secure login account that does not include personal information for research only. Participants will be trained on how to access and use the MOVN private social network group.

Annie text messaging: Participants will be registered in the Annie VA text messaging program to receive tailored, interactive "push" messages with a combination of 1 and 2-way tailored messages on goals, barriers, self-management, etc. (based on data collected in real-time from the Fitbit and barriers identified at baseline).

Fitbit wearable device \& mobile app: The intervention group will be instructed to use the Fitbit for step counts and maximizing the Fitbit mobile app/desktop platform to track all PA, sharing one's Fitbit profile with others (optional leaderboard), and use of all available features.

Primary outcome measure

  • HBCR sessions [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

San Francisco VA Medical Center, San Francisco, CA

Recruiting

San Francisco, California, United States, 94121-1563

Contacts

Linda G Park, PhD MS NP

(925) 348-2174Linda.Park@va.gov

Principal Investigator:

Linda Grace Park, PhD MS NP

Atlanta VA Medical and Rehab Center, Decatur, GA

Recruiting

Decatur, Georgia, United States, 30033-4004

Contacts

Principal Investigator:

Joe R. Nocera, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Cardiovascular Diseases
  • Cardiac Rehabilitation
  • Telemedicine
  • Telerehabilitation
  • Veterans

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-07-22.