RecoveryPlus Telerehab Platform Pilot Study (NCT05804500) | Clinical Trial Compass
CompletedNot Applicable
RecoveryPlus Telerehab Platform Pilot Study
United States75 participantsStarted 2023-03-27
Plain-language summary
In this prospective, single-arm study, we will look at the initiation, participation, sustained engagement, and safety of 100 adult subjects (ages 45 years or older) with recent (within the past 60 days) clinician referral to CR who are offered CTR via the RecoveryPlus platform. We want to understand the effectiveness of the RecoveryPlus platform in engaging participants in CR while remaining a safe alternative for the delivery of evidence-based CR content.
The primary hypothesis of this study is that the RecoveryPlus CTR platform and patient-facing mobile application provide a safe alternative to traditional in-person CR, and demonstrate a high rate of initiation, participation, and engagement in CR exercise programming than traditional modes of CR delivery, as documented in the literature. Current in-person and non-personalized CR programming lacks RecoveryPlus' convenient remote access, easy-to-use digital tools to support independent, autonomous exercise, and a platform to facilitate engagement and feedback between patients and EPs.
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • Older adult \[age 45+\]
* Meets criteria and receives clinician referral to CR
* Within 60 days of referring cardiac event
* Ambulatory
* Under medical management and deemed stable by a clinician
* Low to moderate risk of exercise-induced cardiac event
* Any CR eligible diagnosis in the past 12 months as defined by Medicare Part B coverage excluding heart/heart-lung transplant. Medicare Part B covers CR for patients who experience 1 or more of the following:
* Acute myocardial infarction within the preceding 12 months
* Coronary artery bypass surgery
* Current stable angina pectoris
* Heart valve repair or replacement
* Percutaneous transluminal coronary angioplasty or coronary stenting
* Stable, chronic heart failure is defined as patients with left ventricular ejection fraction of 35% or less and New York Heart Association (NYHA) class II to III symptoms despite being on optimal heart failure medical therapy for at least 6 weeks.
Exclusion Criteria:
* • Body mass index (BMI) equal to or over 35
* Hospitalization or significant decline in health between recruitment-consent and start of the study
* Physical or mental health limitations that prohibit participation in CR exercise activities
* Less than a basic facility with smartphone/tablet
* Lack of access to WIFI
* No active email address
* Hearing and/or sight impairment that would limit the ability to follow exercise videos and instructions.
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.