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Virtual Care Strategies to Improve Participation in Cardiac Rehabilitation Among Veterans (IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05423158
Recruitment Status : Not yet recruiting
First Posted : June 21, 2022
Last Update Posted : August 16, 2022
Sponsor:
Collaborator:
Atlanta VA Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development

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 social media group (Movn), optimized Annie text messaging, VA Video Connect, and connected devices (Fitbits). 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 12 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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Behavioral: d-Coaching Phase 2

Detailed Description:

Underutilization of cardiac rehabilitation (CR). Cardiovascular disease (CVD) is the leading cause of mortality for adults in developed countries, including Veterans. Despite the guideline recommendations for cardiac rehabilitation (CR) for patients with qualifying cardiovascular conditions, participation rates have been dismal over the decades without significant improvement, both within VA and non-VA programs. Only 16.3% of Medicare patients and 10.3% of Veterans participated in center-based CR (CBCR) between 2007 and 2011 after hospitalization for MI, percutaneous coronary intervention, or coronary artery bypass graft surgery. Participation in CR is especially low for older adults (Medicare beneficiaries), Veterans, women, and individuals from underserved populations. Completion of CR programs is also a major problem as 24% and 50% of participants drop-out from CR programs. Barriers for CBCR participation and adherence include considerable travel burden, co-pay for non-VHA programs, time away from work, or being the primary caregiver for children or older adults. Home-based CR (HBCR) and hybrid CR programs (combination of CBCR and HBCR) are alternative approaches to promote exercise and provide education that have been traditionally provided in CBCR. HBCR programs have been studied in depth showing equivalency to CBCR without increased adverse events. However, although the provision of HBCR has alleviated some of the barriers related to CBCR participation, barriers to participation in HBCR include: lack of peer social support, safety concerns for patients at higher risk, lack of face-to-face monitoring and communication, and less patient accountability. While completion rates are marginally higher for HBCR programs than center-based programs, less than half (48%) of Veterans participating in the investigator's SFVAMC HBCR program completed at least nine sessions, well above the VA average of 13%.

Home-based CR in the VA system. Across the VA, only 28% of VAMCs (35/124) have a CBCR program, and low participation is a significant problem with only 8.4% of Veterans participating in at least one session of CBCR at a VA or non-VA contracted site. A growing number of alternative HBCR and hybrid programs now exist in the VA health system after a recent initiative by the Office of Rural health (ORH) to sponsor the expansion of 30 alternative programs nationally. In addition, there have been accelerated efforts by VA CBCR programs to improve access to CR services remotely (equivalent to HBCR) due to the limits on in-person care from the COVID-19 pandemic. VA program evaluations have shown Veterans preferred HBCR compared to CBCR, and Veterans hospitalized at a facility with a HBCR program were 3 to 4 times more likely to participate in HBCR compared to any CBCR program.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: The investigators propose a randomized clinical trial evaluating the effects of HBCR alone (usual care) versus HBCR + d-Coaching. d-Coaching includes a private social media group, optimized Annie text messaging, VA Video Connect, and a wearable device.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virtual Care Strategies to Improve Participation in Cardiac Rehabilitation Among Veterans
Estimated Study Start Date : January 1, 2023
Estimated Primary Completion Date : January 1, 2026
Estimated Study Completion Date : January 1, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: d-Coaching
Will receive home-based cardiac rehabilitation (HBCR) with digital coaching (d-Coaching) intervention
Behavioral: 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.

Other Name: Digital Coaching

No Intervention: Usual Care
Will receive home-based cardiac rehabilitation (HBCR) alone



Primary Outcome Measures :
  1. HBCR sessions [ Time Frame: 3 months ]
    Number of completed home-based cardiac rehabilitation sessions


Secondary Outcome Measures :
  1. Step count [ Time Frame: 3 months ]
    Measured by Fitbit

  2. Functional capacity [ Time Frame: 3 months ]
    6-minute walk test

  3. Sedentary time [ Time Frame: 3 months ]
    Measured by Fitbit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 50 years of age
  2. History of cardiovascular disease that qualified participant for CR (MI, percutaneous coronary intervention, coronary artery bypass grafting, heart failure, valve surgery)
  3. 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05423158


Contacts
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Contact: Linda G Park, PhD MS NP (925) 348-2174 Linda.Park@va.gov
Contact: Julia von Oppenfeld, BA (415) 676-1153 Julia.vonoppenfeld@va.gov

Locations
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United States, California
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121
Contact: Linda G Park, PhD MS NP    (925) 348-2174    Linda.Park@va.gov   
Principal Investigator: Linda Grace Park, PhD MS NP         
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
Contact: Joe R Nocera, PhD    404-321-6111 ext 6354    joe.nocera2@va.gov   
Principal Investigator: Joe R. Nocera, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Atlanta VA Medical Center
Investigators
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Principal Investigator: 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
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT05423158    
Other Study ID Numbers: IIR 21-026
First Posted: June 21, 2022    Key Record Dates
Last Update Posted: August 16, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Cardiovascular Diseases
Cardiac Rehabilitation
Telemedicine
Telerehabilitation
Veterans
Additional relevant MeSH terms:
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Cardiovascular Diseases