Virtual Coaching for Cardiac Rehabilitation

(STRIVE Trial)

Overseen By Julia von Oppenfeld

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Cognitive impairment, Unstable conditions, others

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

Compensation: Varies

Number of Visits: Unknown

286 Participants Needed

Trial Summary

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 consult with the trial coordinators or your healthcare provider for guidance.

What data supports the effectiveness of the treatment Virtual Coaching for Cardiac Rehabilitation?

Research shows that virtual cardiac rehabilitation programs, which include remote coaching, can improve physical activity, clinical outcomes, and patient satisfaction. These programs are effective in reaching patients who cannot attend in-person sessions, and studies have shown improvements in exercise capacity and heart health markers. ^{1 2 3 4 5}

Is virtual coaching for cardiac rehabilitation safe for humans?

Research on virtual coaching for cardiac rehabilitation suggests it is generally safe for humans. Studies have focused on the use of technology like mobile apps and wearable monitors, and while they primarily assess effectiveness, they also indicate patient acceptance and feasibility, implying no major safety concerns. ^{1 2 3 6 7}

How is the Virtual Coaching treatment for cardiac rehabilitation different from other treatments?

Virtual Coaching for cardiac rehabilitation is unique because it uses technology like the Internet and smartphones to provide remote support and guidance to patients, making it accessible to those who cannot attend traditional in-person programs due to geographical or other barriers. This approach allows patients to receive care in their own homes, potentially increasing participation and improving outcomes. ^{1 3 8 9 10}

What is the purpose of this trial?

The proposed research seeks to determine whether virtual coaching and social support focusing on key social cognitive factors will be an effective strategy for maintaining physical activity (PA) after completing cardiac rehabilitation (CR). Despite the well-documented benefits of CR, only 15-50% of individuals continue to exercise 6 months after completing CR.4-6 Thus, after 36 sessions (typically 12 weeks), many patients are left without the support necessary to sustain physical activity (PA) and prevent adverse secondary cardiac events. Though previous research has explored interventions to sustain PA after CR, many studies have been lacking in a theoretical basis, objective measurement of PA, measurement, and analysis of psychosocial and social cognitive factors, and long-term impact on clinical outcomes. Low-cost, pragmatic approaches to maintaining PA after CR is urgently needed for older adults, and virtual technologies offer promising solutions to promote adherence to PA. The three specific aims of the project are to: 1) determine the effect of virtual coaching and social support on adherence to PA (measured by objective step counts) in the intervention vs. control groups; secondary measures will be amount of sedentary time, functional fitness, and self-reported exercise; 2) determine the effect of virtual coaching and social support on psychosocial and social cognitive factors in the intervention vs. control groups; 2a) evaluate the extent to which psychosocial and social cognitive factors mediate the effect of the intervention on PA adherence; 3) examine differences in cardiovascular (CVD) risk factors (blood pressure, lipids, HbA1c, BMI) between groups.

Research Team

Linda Park, PhD, NP

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for individuals who have completed cardiac rehabilitation and are looking to maintain their physical activity levels. Participants should be interested in receiving virtual coaching and social support to help sustain exercise habits.

Inclusion Criteria

I have a history of serious heart conditions that required intensive rehabilitation.

I am 60 years old or older.

Adherence to CR (≥ 50% sessions for ≥ 1 month)

Exclusion Criteria

Cognitive impairment (score 0-2 per Mini-Cog)

Lack of English or Spanish proficiency/literacy

I do not have any severe heart issues, uncontrolled high blood pressure, serious infections, or severe anemia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cardiac Rehabilitation

Participants undergo 36 sessions of cardiac rehabilitation over 12 weeks

12 weeks

Intervention

Participants receive virtual coaching and social support to maintain physical activity

6 months

Weekly virtual check-ins

Follow-up

Participants are monitored for adherence to physical activity and changes in CVD risk factors

12 months

Treatment Details

Interventions

• Virtual Coaching

Trial Overview The study tests if virtual coaching can help people stick with their exercise routines after finishing cardiac rehab. It compares a group getting this extra online support with one that doesn't, measuring steps, fitness, sedentary time, and self-reported exercise.

Participant Groups

Group I: Mobile app + Social Experimental Treatment 1 Intervention

The intervention group will also receive Virtual coaching. The coach will evaluate goals, progress, facilitators (use of the buddy system) and challenges with an emphasis on forming healthy PA habits that will be sustained long-term over the life course. Social support: For the social support component, we will provide ground rules for communication (e.g., positive posts, use of "likes", comments, etc.). Groups will be comprised of 4-6 participants with consecutive recruitment.

Group II: Mobile App Alone Active Control 1 Intervention

Mobile app control group. Exposure time will be similar between participants in both the intervention and control groups as both will have: (1) continuous access to the app for self-monitoring of exercise, blood pressure, and weight; (2) weekly "push" text messages with access to a library of educational content for learning that is self-paced on the app over 6 months; and (3) assigned 1 video per month on a variety of health topics related to older adults via the app that match exposure time (approximately 20-30 minutes) with the intervention group. The videos will be created or resourced from reputable organizations. Our team will send weekly short one-way messages on goals, self-management, etc. that the intervention group will also receive. The 1-way messages will be derived from a bank of 210 secondary prevention messages for CVD (PA, nutrition, stress management, heart disease facts, etc.).

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

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]

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 (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 pilot study involving 15 patients showed that an Internet-based virtual cardiac rehabilitation program (vCRP) is safe and feasible, with no adverse events reported during the 12-week study.

Participants in the vCRP significantly improved key health metrics, including cholesterol levels and exercise capacity, achieving results comparable to traditional cardiac rehabilitation programs, indicating its potential as an effective alternative for patients unable to attend in-person sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of the internet to deliver cardiac rehabilitation at a distance: a pilot study. Zutz, A., Ignaszewski, A., Bates, J., et al.[2022]

Internet-based cardiac rehabilitation (CR) has been shown to improve compliance and physical activity outcomes in patients with heart disease, based on a review of nine studies involving 830 patients.

The studies indicated positive clinical and psychosocial outcomes, with no negative effects reported, suggesting that telemedicine could be a viable option for expanding access to CR, although none of the interventions have yet been implemented as a clinical service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient focused Internet-based approaches to cardiovascular rehabilitation--a systematic review. Munro, J., Angus, N., Leslie, SJ.[2018]

Mobile technologies, including wearable activity monitors and virtual rehabilitation solutions, have the potential to enhance adherence to cardiac rehabilitation, which is crucial for improving quality of life and reducing hospitalizations.

The review of 113 studies showed mixed results regarding the efficacy of virtual cardiac rehabilitation compared to traditional methods, but highlighted the importance of user adherence and long-term engagement as key benefits of these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual healthcare solutions for cardiac rehabilitation: a literature review. Lee, KCS., Breznen, B., Ukhova, A., et al.[2023]

Cardiac Rehabilitation programs are effective in improving patient outcomes, but the COVID-19 pandemic has created challenges for their implementation.

Tele Cardiac Rehabilitation and remote patient monitoring offer a practical and effective alternative to traditional in-person programs, helping to overcome barriers posed by the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation using telemedicine: the need for tele cardiac rehabilitation. Thamman, R., Janardhanan, R.[2021]

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]

Cardiac rehabilitation (CR) is crucial for improving health outcomes in patients with cardiovascular disease, but participation rates are low in India, highlighting the need for innovative delivery methods.

Home-based cardiac rehabilitation (HBCR) offers a promising alternative to traditional center-based programs, utilizing remote coaching and technology to potentially increase access and participation among eligible patients, especially in low- and middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation: Appraisal of current evidence and utility of technology aided home-based cardiac rehabilitation. Rathore, S., Kumar, B., Tehrani, S., et al.[2021]

References

1. 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]

2. Ireland pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

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

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

Utilization of the internet to deliver cardiac rehabilitation at a distance: a pilot study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Patient focused Internet-based approaches to cardiovascular rehabilitation--a systematic review. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Novel Virtual Coaching System Based on Personalized Clinical Pathways for Rehabilitation of Older Adults-Requirements and Implementation Plan of the vCare Project. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Virtual healthcare solutions for cardiac rehabilitation: a literature review. [2023]

8. Singapore pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation using telemedicine: the need for tele cardiac rehabilitation. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

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

10. India pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation: Appraisal of current evidence and utility of technology aided home-based cardiac rehabilitation. [2021]