N/A
N=10
Telehealth-enhanced Hybrid Cardiac Rehabilitation Among Acute Coronary Syndrome Survivors
Acute Coronary Syndrome · Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT05328375 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Number of Participants Who Are Successfully Enrolled Into the Pilot Study Per Month — 0.91 Participants enrolled per month
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Telehealth-enhanced Hybrid CR (Behavioral); Traditional CR (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Are Successfully Enrolled Into the Pilot Study Per Month |
0.91 | — |
| PRIMARY Mean Proportion of CR Sessions Completed by Participants Allocated to the THCR Intervention |
0.87 | — |
| SECONDARY Proportion of Participants That Attend ≥1 CR Session After Randomization in Each Arm |
1.00; 1.00 | — |
| SECONDARY Mean Proportion of CR Sessions Completed by Those Allocated to the Traditional CR Intervention |
0.69 | — |
| SECONDARY Proportion of Participants Who Report Adequate Feasibility of the THCR Intervention |
1.00 | — |
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.
Eligibility Criteria
Inclusion Criteria
- over the age of 18;
- can speak and read English or Spanish;
- confirmed ACS based on ICD-10 codes; and
- had their index event within the past 12 months.
Exclusion Criteria
- severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis that prevent safe or adequate participation;
- high-risk for adverse exercise-related cardiovascular events according to the AACVPR risk stratification criteria;
- participated in >1 CR program session;
- 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);
- 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
- 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).
Data sourced from ClinicalTrials.gov (NCT05328375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.