Trial Outcomes & Findings for Telehealth-enhanced Hybrid Cardiac Rehabilitation Among Acute Coronary Syndrome Survivors (NCT NCT05328375)
NCT ID: NCT05328375
Last Updated: 2025-10-22
Results Overview
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.
COMPLETED
NA
10 participants
During enrollment, 11 months
2025-10-22
Participant Flow
Participant milestones
| Measure |
Telehealth-enhanced Hybrid CR
Participants will receive a hybrid version of cardiac rehabilitation.
|
Traditional CR
Participants will receive a standard of care version of cardiac rehabilitation.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Telehealth-enhanced Hybrid CR
Participants will receive a hybrid version of cardiac rehabilitation.
|
Traditional CR
Participants will receive a standard of care version of cardiac rehabilitation.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Telehealth-enhanced Hybrid Cardiac Rehabilitation Among Acute Coronary Syndrome Survivors
Baseline characteristics by cohort
| Measure |
Telehealth-enhanced Hybrid CR
n=5 Participants
Participants will receive a hybrid version of cardiac rehabilitation.
|
Traditional CR
n=5 Participants
Participants will receive a standard of care version of cardiac rehabilitation.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.1 Years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
63.2 Years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
61.1 Years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Six Minute Walk Test Distance
|
501.7 meters
STANDARD_DEVIATION 113.7 • n=5 Participants
|
452.4 meters
STANDARD_DEVIATION 133.7 • n=7 Participants
|
477.0 meters
STANDARD_DEVIATION 119.8 • n=5 Participants
|
|
Health-related Quality of Life Score
|
78.0 score on a scale
STANDARD_DEVIATION 11.2 • n=5 Participants
|
81.3 score on a scale
STANDARD_DEVIATION 12.6 • n=7 Participants
|
79.7 score on a scale
STANDARD_DEVIATION 11.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: During enrollment, 11 monthsAs 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.
Outcome measures
| Measure |
All Pilot Study Enrollments
n=10 Participants
All participants who successfully enrolled into the pilot study
|
Traditional CR
Participants will receive a standard of care version of cardiac rehabilitation.
|
|---|---|---|
|
Number of Participants Who Are Successfully Enrolled Into the Pilot Study Per Month
|
0.91 Participants enrolled per month
Standard Error 0.21
|
—
|
PRIMARY outcome
Timeframe: Assessed after enrollment (baseline) and until pilot study completion (approximately 12 weeks)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.
Outcome measures
| Measure |
All Pilot Study Enrollments
n=5 Participants
All participants who successfully enrolled into the pilot study
|
Traditional CR
Participants will receive a standard of care version of cardiac rehabilitation.
|
|---|---|---|
|
Mean Proportion of CR Sessions Completed by Participants Allocated to the THCR Intervention
|
0.87 Proportion of CR Sessions Completed
Standard Error 0.13
|
—
|
SECONDARY outcome
Timeframe: During 12-week follow-up period (Up to 12 weeks)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.
Outcome measures
| Measure |
All Pilot Study Enrollments
n=5 Participants
All participants who successfully enrolled into the pilot study
|
Traditional CR
n=5 Participants
Participants will receive a standard of care version of cardiac rehabilitation.
|
|---|---|---|
|
Proportion of Participants That Attend ≥1 CR Session After Randomization in Each Arm
|
1.00 proportion of participants
|
1.00 proportion of participants
|
SECONDARY outcome
Timeframe: Assessed after enrollment (baseline) and until pilot study completion (approximately 12 weeks)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.
Outcome measures
| Measure |
All Pilot Study Enrollments
n=5 Participants
All participants who successfully enrolled into the pilot study
|
Traditional CR
Participants will receive a standard of care version of cardiac rehabilitation.
|
|---|---|---|
|
Mean Proportion of CR Sessions Completed by Those Allocated to the Traditional CR Intervention
|
0.69 Proportion of CR Sessions Completed
Standard Error 0.19
|
—
|
SECONDARY outcome
Timeframe: At study completion (approximately 12 weeks)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 greater feasibility.
Outcome measures
| Measure |
All Pilot Study Enrollments
n=5 Participants
All participants who successfully enrolled into the pilot study
|
Traditional CR
Participants will receive a standard of care version of cardiac rehabilitation.
|
|---|---|---|
|
Proportion of Participants Who Report Adequate Feasibility of the THCR Intervention
|
1.00 Proportion of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3-month post program completion (Week 12)Population: Excludes one Traditional CR participant who moved out of state and did not complete the post-program 6MWT.
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.
Outcome measures
| Measure |
All Pilot Study Enrollments
n=5 Participants
All participants who successfully enrolled into the pilot study
|
Traditional CR
n=4 Participants
Participants will receive a standard of care version of cardiac rehabilitation.
|
|---|---|---|
|
Change in Total Distance Traveled in 6MWT
|
27.12 distance traveled (meters)
Standard Error 8.13
|
71.10 distance traveled (meters)
Standard Error 10.30
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3-month post program completion (Week 12)Population: Excludes two Traditional CR participants: one who moved out of state and did not complete the post-program in-clinic assessments, and one who did not complete the post-program HRQOL assessment.
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, with high scores indicating better health-related quality of life.
Outcome measures
| Measure |
All Pilot Study Enrollments
n=5 Participants
All participants who successfully enrolled into the pilot study
|
Traditional CR
n=3 Participants
Participants will receive a standard of care version of cardiac rehabilitation.
|
|---|---|---|
|
Change in Health-related Quality of Life Score
|
1.3 score on a scale
Standard Error 3.4
|
7.8 score on a scale
Standard Error 1.1
|
Adverse Events
Telehealth-enhanced Hybrid CR
Traditional CR
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Telehealth-enhanced Hybrid CR
n=5 participants at risk
Participants will receive a hybrid version of cardiac rehabilitation.
|
Traditional CR
n=5 participants at risk
Participants will receive a standard of care version of cardiac rehabilitation.
|
|---|---|---|
|
Investigations
Low hemoglobin level
|
20.0%
1/5 • Number of events 1 • Throughout study duration, approx 14 months
|
0.00%
0/5 • Throughout study duration, approx 14 months
|
Additional Information
Dr. Andrea T. Duran, Assistant Professor of Medical Sciences
Columbia University Irving Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place