Clinical trial NCT05328375: Telehealth-enhanced Hybrid Cardiac Rehabilitation Among Acute Coronary Syndrome Survivors
Official title: Implementing Telehealth-enhanced Hybrid Cardiac Rehabilitation (THCR) Among Acute Coronary Syndrome Survivors: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Keywords: Acute Coronary Syndrome
Myocardial Infarction
Cardiac Rehabilitation
Feasibility
Adherence
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-04-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study investigates the feasibility of conducting a randomized controlled trial of telehealth-enhanced hybrid cardiac rehabilitation (THCR) compared with traditional cardiac rehabilitation (CR) among acute coronary syndrome (ACS) survivors. THCR is a novel, hybrid model that targets the same core components as traditional CR (e.g., exercise training, patient education, and risk factor management), but uses a mixture of telehealth, clinic-, and home-based activities to offer 24 CR sessions (5 clinic-based + 19 home-based) over 12 weeks.

Pilot study ran from March 2022 to May 2023. In 2023, intervention became unavailable, due to a telehealth vendor transition across the implementation site's healthcare system, which necessitated new remote patient monitoring platform to offer the experimental arm. Therefore, the study completed with 10 accrued.

Detailed description: Cardiac Rehabilitation (CR) is a Class I, Level A secondary prevention program that significantly reduces reinfarction and mortality rates in acute coronary syndrome (ACS) survivors. Yet, fewer than 30% of eligible cardiac patients participate in and adhere to CR programs in the United States. One promising avenue for increasing CR participation and adherence is a telehealth-enhanced hybrid CR (THCR) model that combines telehealth, clinic- and home-based CR. Several expert groups have strongly endorsed hybrid CR models that integrate telehealth (i.e., mobile apps, remote monitoring devices) because of their ability to offer the "best of both worlds" (i.e., in-clinic supervision/safety and at-home convenience) while also promoting real-time patient-provider communication and reimbursement as a telemedicine service. Despite its potential, the feasibility of and degree to which THCR improves adherence (e.g., # of completed sessions) and clinical outcomes (e.g., functional capacity) relative to traditional CR requires additional investigation. To understand the feasibility of THCR, the investigator will conduct a single center, two-arm, 1:1 parallel group randomized pilot study comparing THCR with traditional CR among ACS patients (N=40) to evaluate the feasibility (e.g., recruitment, adherence) of conducting an adequately powered randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

1. over the age of 18;
2. can speak and read English or Spanish;
3. confirmed ACS based on ICD-10 codes; and
4. had their index event within the past 12 months.

Exclusion Criteria:

1. severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis that prevent safe or adequate participation;
2. high-risk for adverse exercise-related cardiovascular events according to the AACVPR risk stratification criteria;
3. participated in \>1 CR program session;
4. deemed unable to comply with the protocol (either self-selected or indicated during screening that s/he could not complete all requested tasks). This includes, but is not limited to, patients with a level of cognitive impairment indicative of dementia, patients with current alcohol or substance abuse, patients with a significant movement or balance disorder that interferes with walking, patients with impaired circulation or poor perfusion that may impede pulse oximeter readings, and patients with severe mental illness (e.g., schizophrenia);
5. home-based environment deemed incompatible with the protocol and/or that prevent safe or adequate participation (either self-selected or indicated during screening/onboarding process); and
6. unavailable for follow-up for reasons such as terminal illness and imminent plans to leave the United States (as we have migrant or mobile patients due to their citizenship and work issues).

Primary outcomes:
measure: Number of participants who are successfully enrolled into the pilot study per month
timeFrame: Assessed during recruitment and until after enrollment (baseline)
measure: Mean proportion of CR sessions completed by participants allocated to the THCR intervention
timeFrame: Assessed after enrollment (baseline) and until pilot study completion (approximately 12 weeks)
Secondary outcomes:
measure: Proportion of participants that attend ≥1 CR session after randomization in each arm
timeFrame: During 12-week follow-up period (Up to 12 weeks)
measure: Mean proportion of CR sessions completed by those allocated to the traditional CR intervention
timeFrame: Assessed after enrollment (baseline) and until pilot study completion (approximately 12 weeks)
measure: Proportion of participants who report adequate feasibility of the THCR intervention
timeFrame: At study completion (approximately 12 weeks)
Other outcomes:
measure: Change in total distance traveled in 6MWT
timeFrame: Baseline and 3-month post program completion
measure: Change in health-related quality of life score
timeFrame: Baseline and 3-month post program completion
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Andrea T Duran, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Daichi Shimbo, MD
role: STUDY_DIRECTOR
References:
citation: Ritchey MD, Maresh S, McNeely J, Shaffer T, Jackson SL, Keteyian SJ, Brawner CA, Whooley MA, Chang T, Stolp H, Schieb L, Wright J. Tracking Cardiac Rehabilitation Participation and Completion Among Medicare Beneficiaries to Inform the Efforts of a National Initiative. Circ Cardiovasc Qual Outcomes. 2020 Jan;13(1):e005902. doi: 10.1161/CIRCOUTCOMES.119.005902. Epub 2020 Jan 14.
citation: 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.
citation: Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, Jaffe AS, Jneid H, Kelly RF, Kontos MC, Levine GN, Liebson PR, Mukherjee D, Peterson ED, Sabatine MS, Smalling RW, Zieman SJ; ACC/AHA Task Force Members. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 23;130(25):e344-426. doi: 10.1161/CIR.0000000000000134. Epub 2014 Sep 23. No abstract available.
citation: Smith SC Jr, Benjamin EJ, Bonow RO, Braun LT, Creager MA, Franklin BA, Gibbons RJ, Grundy SM, Hiratzka LF, Jones DW, Lloyd-Jones DM, Minissian M, Mosca L, Peterson ED, Sacco RL, Spertus J, Stein JH, Taubert KA; World Heart Federation and the Preventive Cardiovascular Nurses Association. AHA/ACCF Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and other Atherosclerotic Vascular Disease: 2011 update: a guideline from the American Heart Association and American College of Cardiology Foundation. Circulation. 2011 Nov 29;124(22):2458-73. doi: 10.1161/CIR.0b013e318235eb4d. Epub 2011 Nov 3. No abstract available.
citation: Imran HM, Baig M, Erqou S, Taveira TH, Shah NR, Morrison A, Choudhary G, Wu WC. Home-Based Cardiac Rehabilitation Alone and Hybrid With Center-Based Cardiac Rehabilitation in Heart Failure: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2019 Aug 20;8(16):e012779. doi: 10.1161/JAHA.119.012779. Epub 2019 Aug 17.