What side effects are associated with this type of intervention?

Common treatments in telemedicine, such as virtual world-based cardiac rehabilitation programs, generally have minimal physical side effects. However, patients may experience technical issues like connectivity problems, which can disrupt the continuity of care. Additionally, there can be challenges in effectively observing nonverbal cues and ensuring patient privacy. Some patients might feel isolated or less connected to their healthcare providers compared to in-person visits. These factors can potentially impact the overall effectiveness and patient satisfaction with the treatment.

What prior FDA approvals exist?

The FDA has approved various telemedicine and digital health solutions aimed at managing chronic conditions, including cardiac rehabilitation. While specific approvals for virtual world-based cardiac rehabilitation programs like Destination Cardiac Rehab are not detailed, the FDA has supported digital health innovations such as remote monitoring devices, telehealth platforms, and mobile health applications that facilitate remote patient management and rehabilitation. These approvals reflect a broader trend towards integrating telemedicine into chronic disease management, enhancing patient access to care, and improving adherence to rehabilitation protocols.

What other types of research exist?

Promising alternatives to Destination Cardiac Rehab for telemedicine patients include: 1) Home-based exercise programs with wearable technology and telephone coaching, which have shown efficacy in improving walking performance and functional status in patients with peripheral artery disease. 2) Digital Cognitive Behavioral Therapy for Insomnia (CBT-I), which has demonstrated improvements in sleep-related quality of life and psychological well-being, and could be adapted for cardiac rehabilitation. 3) Mobile phone-based interventions for smoking cessation, which have been effective in promoting smoking cessation and could be integrated into a comprehensive cardiac rehabilitation program. 4) Virtual reality-based exposure therapy, which has been used successfully for PTSD and could be adapted for stress management in cardiac patients.

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Virtual vs Center-Based Cardiac Rehab for Cardiovascular Disease (VWCR Trial)

N/A

Waitlist Available

Led By LaPrincess Brewer, M.D., M.P.H.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months and 6 months post-randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a home-based virtual rehab program for heart patients. It aims to make it easier for them to follow their rehab by providing online education, health tracking, social support, and video calls with healthcare professionals. The goal is to see if this virtual program is as effective as traditional in-person rehab.

Who is the study for?

This trial is for adults over 18 who need cardiac rehab based on specific health conditions like recent heart attacks, surgeries, or stable heart issues. They must be able to use the internet and have an email address. It's not for high-risk patients with severe heart problems, those needing constant support, non-English speakers, or pregnant women.

What is being tested?

The study compares a new Virtual World-Based Cardiac Rehabilitation (VWCR) program called 'Destination Cardiac Rehab' with traditional center-based rehabilitation to see if it's just as effective and whether people stick with it.

What are the potential side effects?

Since this trial involves exercise and education programs rather than medication, side effects are minimal but may include typical risks associated with physical activity such as muscle soreness or strain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months and 6 months post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months and 6 months post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months and 6 months post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Life's Essential 8 component: Blood Glucose

Life's Essential 8 component: Blood Pressure

Life's Essential 8 component: Body Mass Index (BMI)

+7 more

Secondary study objectives

Diet Self-efficacy

Diet Self-regulation

Diet Social Support

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual World-Based Cardiac Rehab (VWCR)Experimental Treatment1 Intervention

Telehealth delivery of cardiac rehabilitation via Second Life virtual world platform. 12-week, home-based program.

Group II: Center-Based Cardiac Rehab (CBCR)Active Control1 Intervention

Standard of care for participants' center-based cardiac rehabilitation program. Traditional 12-week, in-person program.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Telemedicine treatments, such as virtual world-based cardiac rehabilitation programs like 'Destination Cardiac Rehab,' leverage digital platforms to deliver structured exercise, education, and counseling remotely. These programs use interactive virtual environments to simulate real-world activities, providing patients with a safe and controlled setting to perform rehabilitation exercises. The mechanisms of action include improving cardiovascular health through guided physical activity, enhancing patient engagement and adherence through interactive and immersive experiences, and providing continuous monitoring and feedback from healthcare providers. This approach is particularly beneficial for telemedicine patients as it offers convenient access to essential rehabilitation services, reduces the need for travel, and allows for personalized care in the comfort of their own homes.

Physical therapy interventions for older people with vertigo, dizziness and balance disorders addressing mobility and participation: a systematic review.Satisfaction with care in post-stroke patients undergoing a telerehabilitation programme at home.