Coronary Artery Disease Clinical Trial
Official title:
Safety and Engagement in Cardiac Rehabilitation With the RecoveryPlus Telerehabilitation Platform: A Prospective, Single-arm, Pilot Study
Verified date | January 2024 |
Source | NODEHealth Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Completed |
Enrollment | 75 |
Est. completion date | January 15, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility | 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. - Non-English-speaking - Unable to read in English. |
Country | Name | City | State |
---|---|---|---|
United States | NODEHealth Foundation | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
NODEHealth Foundation |
United States,
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. — View Citation
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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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 6-minute WALK TEST | This endpoint will be defined as the difference in fitness as measured by performance on a 6-minute walk test from baseline to endline. The 6-minute walk test is a widely used and well documented measure of aerobic exercise capacity used to indicate change in fitness.7 In this test, one measures the distance an individual is able to walk over a total of six minutes on a hard flat surface. Per routine RecoveryPlus practice, the EP will instruct participants virtually on completion of the test at baseline and again at endline. | 3 months | |
Secondary | RESTING HEART RATE | This endpoint will be defined as the difference in fitness as measured by resting heart rate from baseline to endline. Resting heart rate is positively associated with mortality and is known to lower with regular exercise. Per routine RecoveryPlus practice, the EP will instruct participants virtually on completion of resting heart rate assessment at baseline and again at endline. | 3 months | |
Secondary | QUALITY OF LIFE | QoL will be defined as the difference in score on the Short-Form Health Survey (SF-36), a validated and commonly used measure of patient perceived quality of life and functional health and wellbeing, from baseline to endline.8 During the initial teleheath evaluation appointment, EPs will provide a link to a secure web form and facilitate participant completion of the baseline SF-36 online; after 12 weeks, EPs will facilitate completion of an endline SF-36 using the same process. | 3 months |
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