Virtual Care Strategies to Improve Participation in Cardiac Rehabilitation Among Veterans

NCT05423158 | Recruiting Phase 2

• 1 other identifier: IIR 21-026
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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

Keywords

Cardiovascular Diseases; Cardiac Rehabilitation; Telemedicine; Telerehabilitation; Veterans

Outcome Measures

Primary Outcomes (1)

• HBCR sessions

  Number of completed home-based cardiac rehabilitation sessions

  3 months

Secondary Outcomes (3)

• Physical activity

  3 months

• Functional capacity

  3 months

• Sedentary time

  3 months

Study Arms (2)

d-Coaching

EXPERIMENTAL

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

Behavioral: d-Coaching

Usual Care

NO INTERVENTION

Will receive home-based cardiac rehabilitation (HBCR) alone

Interventions

d-Coaching BEHAVIORAL

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.

Also known as: Digital Coaching

d-Coaching

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Atlanta VA Medical Center: collaborator
• VA Palo Alto Health Care System: collaborator
• VA Ann Arbor Healthcare System: collaborator
• Malcom Randall VA Medical Center: collaborator

Study Sites (2)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563, United States

RECRUITING

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Linda Grace Park, PhD MS NP

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

• Joe R. Nocera, PhD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda G Park, PhD MS NP

CONTACT

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

Julia von Oppenfeld, BA

CONTACT

(415) 676-1153; Julia.vonoppenfeld@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The investigators propose a randomized clinical trial evaluating the effects of HBCR alone (usual care) versus HBCR + d-Coaching. d-Coaching includes a private group for intervention participants with direct messaging on the Connecteam mobile app and engagement sessions via VA Video Connect.

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: March 15, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)