RecoveryPlus Telerehab Platform Pilot Study

NCT05804500 | Completed

• 1 other identifier: Pro00070335
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Diseases; Angina, Stable; Angina Pectoris; Myocardial Ischemia; Myocardial Infarction; Coronary Artery Disease; Coronary Artery Stenosis; Valve Heart Disease; Valve Disease, Heart

Outcome Measures

Primary Outcomes (4)

• INITIATION

  Initiation will be defined as the proportion of enrolled screen-eligible patients who completed all baseline assessments and completed the initial CTR session.

  3 months

• PARTICIPATION

  Participation will be defined as the proportion of prescribed CTR sessions per participant that are completed (51% or more of prescribed session length completed) throughout the 12-week study period.

  3 months

• SUSTAINED ENGAGEMENT

  Sustained engagement will be defined as the proportion of enrolled participants who had a minimum of 1 completed session, synchronous and/or asynchronous, per week (within each 7day interval from the initial session) for at least 9 weeks of the 12-week study period.

  3 months

• SAFETY

  Safety will be measured as the total number of adverse events over the entire course of the 12-week study period.

  3 months

Secondary Outcomes (3)

• 6-minute WALK TEST

  3 months

• RESTING HEART RATE

  3 months

• QUALITY OF LIFE

  3 months

Study Arms (1)

Cardiac Telerehabilitation Arm

EXPERIMENTAL

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.

Behavioral: Cardiac Telerehabilitation (CTR) via the RecoveryPlus platform

Interventions

Cardiac Telerehabilitation (CTR) via the RecoveryPlus platform BEHAVIORAL

RecoveryPlus has developed an innovative CTR platform for patients with CVD that leverages: (1) video conferencing functionality (Zoom) for synchronous telehealth sessions of CR instruction for patients and licensed exercise physiologists (EPs), (2) a patient-facing mobile application delivering asynchronous exercise videos, and (3) a health care provider web portal for clinicians and EPs. The RecoveryPlus platform includes the ability for EPs and clinicians to monitor patient clinical data (e.g., heart rate) and input (e.g., rating of difficulty for individual exercises) and tailor individual patient regimens regularly for increased safety and optimal outcomes.

Cardiac Telerehabilitation Arm

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NODEHealth Foundation: lead

Study Sites (1)

NODEHealth Foundation

Washington D.C., District of Columbia, 20001, United States

Location

Related Publications (9)

• Scheinowitz M, Harpaz D. Safety of cardiac rehabilitation in a medically supervised, community-based program. Cardiology. 2005;103(3):113-7. doi: 10.1159/000083433. Epub 2005 Jan 19.

  PMID: 15665529 BACKGROUND

• Thompson PD, Franklin BA, Balady GJ, Blair SN, Corrado D, Estes NA 3rd, Fulton JE, Gordon NF, Haskell WL, Link MS, Maron BJ, Mittleman MA, Pelliccia A, Wenger NK, Willich SN, Costa F; American Heart Association Council on Nutrition, Physical Activity, and Metabolism; American Heart Association Council on Clinical Cardiology; American College of Sports Medicine. Exercise and acute cardiovascular events placing the risks into perspective: a scientific statement from the American Heart Association Council on Nutrition, Physical Activity, and Metabolism and the Council on Clinical Cardiology. Circulation. 2007 May 1;115(17):2358-68. doi: 10.1161/CIRCULATIONAHA.107.181485.

  PMID: 17468391 BACKGROUND

• Pavy B, Iliou MC, Meurin P, Tabet JY, Corone S; Functional Evaluation and Cardiac Rehabilitation Working Group of the French Society of Cardiology. Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation. Arch Intern Med. 2006 Nov 27;166(21):2329-34. doi: 10.1001/archinte.166.21.2329.

  PMID: 17130385 BACKGROUND

• Thomas RJ, Beatty AL, Beckie TM, Brewer LC, Brown TM, Forman DE, Franklin BA, Keteyian SJ, Kitzman DW, Regensteiner JG, Sanderson BK, Whooley MA. Home-Based Cardiac Rehabilitation: A Scientific Statement From the American Association of Cardiovascular and Pulmonary Rehabilitation, the American Heart Association, and the American College of Cardiology. Circulation. 2019 Jul 2;140(1):e69-e89. doi: 10.1161/CIR.0000000000000663. Epub 2019 May 13.

  PMID: 31082266 BACKGROUND

• Meinhart F, Stutz T, Sareban M, Kulnik ST, Niebauer J. Mobile Technologies to Promote Physical Activity during Cardiac Rehabilitation: A Scoping Review. Sensors (Basel). 2020 Dec 24;21(1):65. doi: 10.3390/s21010065.

  PMID: 33374322 BACKGROUND

• Kemps HMC, Brouwers RWM, Cramer MJ, Jorstad HT, de Kluiver EP, Kraaijenhagen RA, Kuijpers PMJC, van der Linde MR, de Melker E, Rodrigo SF, Spee RF, Sunamura M, Vromen T, Wittekoek ME; Committee for Cardiovascular Prevention and Cardiac Rehabilitation of the Netherlands Society of Cardiology. Recommendations on how to provide cardiac rehabilitation services during the COVID-19 pandemic. Neth Heart J. 2020 Jul;28(7-8):387-390. doi: 10.1007/s12471-020-01474-2.

  PMID: 32676982 BACKGROUND

• Bellet RN, Adams L, Morris NR. The 6-minute walk test in outpatient cardiac rehabilitation: validity, reliability and responsiveness--a systematic review. Physiotherapy. 2012 Dec;98(4):277-86. doi: 10.1016/j.physio.2011.11.003. Epub 2012 May 16.

  PMID: 23122432 BACKGROUND

• Lins L, Carvalho FM. SF-36 total score as a single measure of health-related quality of life: Scoping review. SAGE Open Med. 2016 Oct 4;4:2050312116671725. doi: 10.1177/2050312116671725. eCollection 2016.

  PMID: 27757230 BACKGROUND

• Bilbrey T, Martin J, Zhou W, Bai C, Vaswani N, Shah R, Chokshi S, Chen X, Bhusri S, Niemi S, Meng H, Lei Z. A Dual-Modality Home-Based Cardiac Rehabilitation Program for Adults With Cardiovascular Disease: Single-Arm Remote Clinical Trial. JMIR Mhealth Uhealth. 2024 Oct 1;12:e59098. doi: 10.2196/59098.

  PMID: 39150858 DERIVED

MeSH Terms

Conditions

Heart Diseases; Angina, Stable; Angina Pectoris; Myocardial Ischemia; Myocardial Infarction; Coronary Artery Disease; Coronary Stenosis; Heart Valve Diseases

Interventions

Receptors, Calcitonin

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Peptide

Study Officials

• Nitin G Vaswani, MD

  NODEHealth Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: March 27, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 15, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)