Virtual Care for Cardiac Rehabilitation

(IMPACT Trial)

Recruiting at 1 trial location

Overseen By Julia von Oppenfeld, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, Unstable conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help Veterans complete their home-based cardiac rehabilitation (CR) by incorporating digital coaching (d-Coaching) into their routine. The researchers aim to determine if a social media platform for support and motivation can help Veterans adhere to their CR program, improve physical fitness, and enhance overall well-being. Participants will either follow regular home-based CR or try the new method with added digital coaching. Veterans with a history of heart disease who have been referred for home-based CR and are not currently enrolled in center-based programs may be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering Veterans a chance to contribute to innovative cardiac care solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that adding digital coaching (d-Coaching) to home-based cardiac rehabilitation (HBCR) can increase participation and improve health in people with heart disease. Past patients found this method easy to use. Similar studies have reported that digital peer support and education are safe, with no major side effects.

Digital tools, such as private social media groups for support, have not caused significant problems in related research. Participants generally manage digital interactions and educational content well. Evidence suggests that d-Coaching safely complements traditional rehabilitation efforts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the d-Coaching approach for cardiac rehabilitation because it integrates digital coaching into home-based cardiac rehab. Unlike traditional programs that rely on in-person sessions, d-Coaching allows patients to engage in rehabilitation from the comfort of their homes while receiving personalized guidance through digital platforms. This method not only provides more flexibility and convenience but also has the potential to increase patient adherence and engagement, leading to better overall outcomes in cardiac health.

What evidence suggests that this trial's treatments could be effective for cardiac rehabilitation?

This trial will compare two approaches to home-based cardiac rehabilitation (HBCR): one group will receive HBCR with digital coaching (d-Coaching), while the other group will receive HBCR alone. Research has shown that digital coaching helps people adhere to HBCR programs. One study found that adding d-Coaching led to more completed rehab sessions and improved physical fitness. Digital coaching supports participants by offering education, personalized feedback, and motivation. It also provides social support through online communities, boosting confidence and self-control. These elements are crucial for maintaining long-term physical activity and enhancing overall health. ^{2 6 7 8 9}

Who Is on the Research Team?

Linda Grace Park, PhD MS NP

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Joe R. Nocera, PhD

Principal Investigator

Atlanta VA Medical and Rehab Center, Decatur, GA

Are You a Good Fit for This Trial?

This trial is for Veterans aged 50 or older with a history of cardiovascular disease who have been referred to home-based cardiac rehabilitation (CR). They must speak and read English, as the digital coaching will be in English. Those already participating in center-based CR, with cognitive impairments, unstable clinical conditions, or insufficient English proficiency are excluded.

Inclusion Criteria

I have a history of heart disease that required cardiac rehabilitation.

I have been referred for a home-based Phase II cardiac rehab program.

I am 50 years old or older.

Exclusion Criteria

I do not have any unstable health conditions like irregular heartbeats or uncontrolled high blood pressure.

Participation in center-based Phase II CR.

Cognitive impairment (per Mini-Cog)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive home-based cardiac rehabilitation (HBCR) with or without digital coaching (d-Coaching) intervention

3 months

Virtual visits using VA Video Connect and connected devices

Follow-up

Participants are monitored for functional capacity, physical activity, and psychosocial outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

• d-Coaching

Trial Overview

The study is testing whether adding digital coaching (d-Coaching) to home-based cardiac rehab improves participation and health outcomes. It includes a private social media group for support, personalized feedback via text messaging and video calls, and monitoring through connected devices like Fitbits.

How Is the Trial Designed?

Group I: d-Coaching Experimental Treatment 1 Intervention

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

Group II: Usual Care Active Control 1 Intervention

Will receive home-based cardiac rehabilitation (HBCR) alone

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Palo Alto VA Medical Center

Collaborator

Trials

1

Recruited

150+

VA Ann Arbor Healthcare System

Collaborator

Trials

19

Recruited

10,300+

Malcom Randall VA Medical Center

Collaborator

Trials

8

Recruited

430+

VA Palo Alto Health Care System

Collaborator

Trials

97

Recruited

58,500+

Atlanta VA Medical Center

Collaborator

Trials

28

Recruited

69,700+

Published Research Related to This Trial

A virtual cardiac rehabilitation program (vCRP) was found to be an effective and convenient alternative to traditional in-person programs, leading to clinical improvements and high patient satisfaction among participants in a 16-month randomized controlled trial.

The vCRP improved access to healthcare professionals and supported healthier lifestyle choices, although challenges like computer literacy and perceptions of virtual care were identified as barriers to participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The experiences of patients undertaking a 'virtual' cardiac rehabilitation program. Banner, D., Lear, S., Kandola, D., et al.[2018]

Home-based cardiac rehabilitation (CR) programs, like the Care Assessment Platform (CAP), are as effective as traditional center-based programs and can improve access for patients, especially in remote areas.

The CAP utilizes information and communication technologies (ICT) to enhance patient engagement and monitoring, leading to high usage rates and acceptance among participants, which may improve overall outcomes in cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uptake of a technology-assisted home-care cardiac rehabilitation program. Varnfield, M., Karunanithi, MK., Särelä, A., et al.[2020]

Cardiac rehabilitation (CR) programs significantly reduce future cardiac events and mortality, but only about 10% of eligible patients participate due to geographical barriers.

The development of virtual CR programs, utilizing technologies like the Internet and smartphones, shows promise in improving patient access and has demonstrated positive effects on clinical outcomes in small randomized trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Delivery of Cardiac Rehabilitation Using Communications Technologies: The "Virtual" Cardiac Rehabilitation Program. Lear, SA.[2019]

Patients with coronary artery disease (CAD) have significant information and support needs after hospital discharge, particularly regarding their condition, treatment procedures, medication, physical activity, and psychological distress, as identified through interviews and literature review involving 55 participants.

A remote coaching program was developed to address these needs, focusing on educating patients about CAD, medication adherence, safe physical activities, and understanding psychosocial impacts, thereby facilitating a smoother transition from hospital discharge to cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a Remote Coaching Program to Bridge the Gap From Hospital Discharge to Cardiac Rehabilitation: Intervention Mapping Study. Keessen, P., van Duijvenbode, IC., Latour, CH., et al.[2022]

A digital health intervention (DHI) combined with remote cardiac rehabilitation (CR) significantly improved access to CR, with 90% of participants completing the program out of 258 who consented from 1,643 referrals.

Participants in the DHI showed notable improvements in their 6-minute walk test distance and reductions in low-density lipoprotein cholesterol, along with a decrease in smoking rates, all without any reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a patient-centered digital health intervention in patients referred to cardiac rehabilitation: the Smart HEART clinical trial. Harzand, A., Alrohaibani, A., Idris, MY., et al.[2023]

Cardiac telerehabilitation significantly improves long-term cardiopulmonary fitness in patients with coronary artery disease (CAD), showing a mean difference of 1.61 in peak oxygen uptake compared to traditional center-based rehabilitation.

Patients participating in cardiac telerehabilitation also experience an improvement in quality of life, with a mean difference of 0.92, while maintaining a high completion rate of 80% and a low incidence of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longer-Term Effects of Cardiac Telerehabilitation on Patients With Coronary Artery Disease: Systematic Review and Meta-Analysis. Zhong, W., Liu, R., Cheng, H., et al.[2023]

A study involving 11 patients (5 with heart failure and 6 with ischemic heart disease) assessed their perceptions of technology and remote monitoring in cardiac rehabilitation, revealing excellent usability results for heart failure patients and good results for those with ischemic heart disease.

The findings highlight the importance of patient feedback in developing a tailored rehabilitation program, especially given the limited access to traditional cardiac rehabilitation services in Romania, which has increased patient interest and motivation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Perception When Transitioning from Classic to Remote Assisted Cardiac Rehabilitation. Busnatu, ȘS., Pană, MA., Lăcraru, AE., et al.[2022]

Complex e-coaching programs for cardiac rehabilitation were found to be more effective than usual care in improving physical capacity, clinical status, and psychosocial health, with strong evidence for long-term benefits based on a review of 19 randomized controlled trials.

In contrast, basic e-coaching programs showed limited or no evidence of effectiveness, highlighting the need for more detailed descriptions of e-coaching content to optimize cardiac rehabilitation care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-coaching: New future for cardiac rehabilitation? A systematic review. Veen, EV., Bovendeert, JFM., Backx, FJG., et al.[2018]

Cardiac rehabilitation is highly beneficial for various cardiovascular conditions but is often underutilized, indicating a need for improved patient engagement and support.

Digital technology can enhance traditional cardiac rehabilitation by providing flexible, accessible interventions that improve health outcomes and promote health equity, as outlined in this American Heart Association advisory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Technologies in Cardiac Rehabilitation: A Science Advisory From the American Heart Association. Golbus, JR., Lopez-Jimenez, F., Barac, A., et al.[2023]

Digital cardiac rehabilitation (CR) significantly improves health outcomes such as daily steps, physical activity, medication adherence, and cholesterol levels, showing effectiveness comparable to traditional center-based CR, based on a review of 25 randomized controlled trials.

Effective digital CR programs often incorporate behavior change techniques like feedback and monitoring, goal setting, and social support, but there is a need for better reporting of intervention details to enhance future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behaviour change techniques and intervention characteristics in digital cardiac rehabilitation: a systematic review and meta-analysis of randomised controlled trials. Kenny, E., Coyne, R., McEvoy, JW., et al.[2023]

Healthcare professionals view digital patient educational programs as a valuable complement to traditional cardiac rehabilitation methods for patients with coronary artery disease, emphasizing the need for proper implementation support and time to adapt to new routines.

The study suggests that hybrid models combining digital and in-person education could enhance patient care by catering to individual preferences, highlighting the importance of accessibility and patient involvement in their rehabilitation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare professionals' perceptions of using a digital patient educational programme as part of cardiac rehabilitation in patients with coronary artery disease - a qualitative study. Danielsbacka, J., Feldthusen, C., Bäck, M.[2023]

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