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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment d-Coaching, Digital Coaching, Virtual Social Support, Interactive Digital Multi-media Education for cardiac rehabilitation?

Research shows that virtual cardiac rehabilitation programs, which include digital coaching and education, are effective in improving patient outcomes like physical activity and medication adherence. These programs are also accessible and convenient, making them a good alternative to traditional, in-person rehabilitation. ^{1 2 3 4 5}

Is virtual cardiac rehabilitation safe for humans?

Research on virtual cardiac rehabilitation, which includes digital coaching and remote monitoring, suggests it is generally safe for humans. Studies have shown positive patient perceptions and acceptance, indicating that these digital interventions are well-received and can be safely integrated into cardiac care. ^{3 6 7 8 9}

How does virtual care for cardiac rehabilitation differ from other treatments for heart conditions?

Virtual care for cardiac rehabilitation is unique because it uses technology like the Internet and smartphones to deliver rehabilitation services remotely, making it accessible to patients who cannot attend traditional in-person programs due to geographical barriers. This approach allows patients to receive support and guidance from healthcare professionals in their own homes, improving access and potentially increasing participation rates. ^{1 5 8 10 11}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 Palo Alto Health Care System

Collaborator

Trials

97

Recruited

58,500+

Atlanta VA Medical Center

Collaborator

Trials

28

Recruited

69,700+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The experiences of patients undertaking a 'virtual' cardiac rehabilitation program. [2018]

2. England 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. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

E-coaching: New future for cardiac rehabilitation? A systematic review. [2018]

4. England 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. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Design of a Remote Coaching Program to Bridge the Gap From Hospital Discharge to Cardiac Rehabilitation: Intervention Mapping Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Digital Technologies in Cardiac Rehabilitation: A Science Advisory From the American Heart Association. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Patient Perception When Transitioning from Classic to Remote Assisted Cardiac Rehabilitation. [2022]

8. England pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Effects of a patient-centered digital health intervention in patients referred to cardiac rehabilitation: the Smart HEART clinical trial. [2023]

10. Canada pubmed.ncbi.nlm.nih.gov

Longer-Term Effects of Cardiac Telerehabilitation on Patients With Coronary Artery Disease: Systematic Review and Meta-Analysis. [2023]

11. Australia pubmed.ncbi.nlm.nih.gov

Uptake of a technology-assisted home-care cardiac rehabilitation program. [2020]