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Telehealth-enhanced Hybrid Cardiac Rehabilitation Among Acute Coronary Syndrome Survivors
NA trial testing Telehealth-enhanced Hybrid CR in Acute Coronary Syndrome in 10 participants. Completed in 1 May 2023.
| Lead sponsor | Columbia University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 10 |
| Start date | 11 March 2022 |
| Primary completion | 26 April 2023 |
| Estimated completion | 1 May 2023 |
| Sites | 1 location across United States |
Columbia University
18 and older, any sex, with Acute Coronary Syndrome or Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
As a measure of enrollment feasibility, the investigator will assess the number of participants who completed recruitment activities and were successfully consented and enrolled into the pilot study per month.
| Group | Value | 95% CI |
|---|---|---|
| All Pilot Study Enrollments | 0.91 | ± 0.21 |
As a measure of THCR adherence, the investigator will assess the proportion of CR sessions completed by participants allocated to the THCR intervention, which includes 19 home-based + 5 clinic-based sessions.
| Group | Value | 95% CI |
|---|---|---|
| Telehealth-enhanced Hybrid CR | 0.87 | ± 0.13 |
This is to assess the feasibility of program initiation among participants allocated to each arm. Participants who attended more than 1 CR session will be tallied. Numerator = total number of participants randomized into each arm who attended at least 1 CR session. Denominator = total number of participants randomized into each arm.
| Group | Value | 95% CI |
|---|---|---|
| Telehealth-enhanced Hybrid CR | 1.00 | |
| Traditional CR | 1.00 |
As a measure of traditional CR adherence, the investigator will assess the proportion of CR sessions completed by those allocated to the traditional CR intervention, which includes 24 clinic-based sessions.
| Group | Value | 95% CI |
|---|---|---|
| Traditional CR | 0.69 | ± 0.19 |
This outcome assesses the proportion of participants in the THCR arm who report an average score ≥4 on the Feasibility of Intervention Measure (FIM), a 4-item scale evaluating patient-perceived feasibility of the intervention. Each item is rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). Individual item scores are summed (possible range: 4 to 20) and averaged (possible range: 1 to 5). Participants with a mean score ≥4 ("agree" or "strongly agree" on average) are considered to perceive the intervention as adequately feasible. Higher scores indicate g
| Group | Value | 95% CI |
|---|---|---|
| Telehealth-enhanced Hybrid CR | 1.00 |
This is to measure pre-to-post program change in functional capacity (using the six-minute walk test \[6MWT\]) among THCR and, separately, traditional CR participants. The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The total distance (meters) traveled over a time period of six minutes is used as the outcome by which to compare changes in performance capacity.
| Group | Value | 95% CI |
|---|---|---|
| Telehealth-enhanced Hybrid CR | 27.12 | ± 8.13 |
| Traditional CR | 71.10 | ± 10.30 |
This is to measure pre-to-post program change in health-related quality of life (Duke health profile questionnaire \[DUKE; physical, mental, social, and general health composite scores\]) among THCR and, separately, traditional CR participants (composite score). The DUKE is a 17-item self-report questionnaire for measuring generic health-related quality of life over a 1-week time period. Responses are scored to calculate physical health, mental health, and social health scores, which are then summed and divided by 3 to obtain a general health score. The general health score ranges from 0 - 100
| Group | Value | 95% CI |
|---|---|---|
| Telehealth-enhanced Hybrid CR | 1.3 | ± 3.4 |
| Traditional CR | 7.8 | ± 1.1 |
Time frame: Throughout study duration, approx 14 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Telehealth-enhanced Hybrid… | Traditional CR |
|---|---|---|---|
| Low hemoglobin level | Investigations | — | — |
Data from ClinicalTrials.gov NCT05328375 adverse events section.
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.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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