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NCT05804500Completed

RecoveryPlus Telerehab Platform Pilot Study

Safety and Engagement in Cardiac Rehabilitation With the RecoveryPlus Telerehabilitation Platform: A Prospective, Single-arm, Pilot Study

Source: ClinicalTrials.gov · Last updated 19 Jan 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
75 (actual)
First submitted
27 Mar 2023
Start date
27 Mar 2023
Primary completion date
31 Dec 2023
Lead sponsor
NODEHealth Foundation
NCT number
NCT05804500

What you commit to

  • Study type: Interventional
  • Participants enrolled: 75
  • From 27 Mar 2023 to the primary completion date, 31 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • • 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.
    • Non-English-speaking
    • Unable to read in English.

Who the study is looking for

  • • 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.

Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
NODEHealth Foundation
Coordinator of this site? Confirm its status
Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.