Acute Coronary Syndrome, Myocardial Infarction
Conditions
Keywords
Acute Coronary Syndrome, Myocardial Infarction, Cardiac Rehabilitation, Feasibility, Adherence
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.
Interventions
BEHAVIORALTelehealth-enhanced Hybrid CR
Participants in this group attend a total of 24 CR sessions (5 clinic-based + 19 home-based) over a 12-week period. Clinic-based sessions occur during the first week of the program and at the end of each month. Home-based sessions take place remotely once or twice per week via telehealth, depending on the week of the program. Patients are provided with onboarding sessions, remote patient monitoring devices (tablet, pulse oximeter, blood pressure monitor and cuff) and home-based exercise equipment (e.g., stationary bike and weights). Each CR session (clinic and home) is 60 minutes in duration and includes aerobic and resistance exercise training. Patients will also be asked to complete educational videos, as well as document their physical activity, dietary intake, medication management and homework sessions via surveys. Patients will be encouraged (but not required) to achieve ≥30 minutes of moderate aerobic activity, such as brisk walking, on ≥5 days per week.
BEHAVIORALTraditional CR
Participants in this group attend a total of 24 clinic-based CR sessions according to standard of care protocols over a 12-week period. Each CR session is 60 minutes in duration and includes aerobic and resistance exercise training. In addition to scheduled sessions, patients will be asked to complete educational videos, as well as document their physical activity, dietary intake, medication management and homework sessions via surveys. Patients will be encouraged (but not required) to achieve ≥30 minutes of moderate aerobic activity, such as brisk walking, on ≥5 days per week.
Sponsors
National Institutes of Health (NIH)
National Center for Advancing Translational Sciences (NCATS)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Are Successfully Enrolled Into the Pilot Study Per Month | During enrollment, 11 months | 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. |
| Mean Proportion of CR Sessions Completed by Participants Allocated to the THCR Intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Who Report Adequate Feasibility of the THCR Intervention | 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. |
| Mean Proportion of CR Sessions Completed by Those Allocated to the Traditional CR Intervention | 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. |
| Proportion of Participants That Attend ≥1 CR Session After Randomization in Each Arm | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Distance Traveled in 6MWT | Baseline and 3-month post program completion (Week 12) | 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. |
| Change in Health-related Quality of Life Score | Baseline and 3-month post program completion (Week 12) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telehealth-enhanced Hybrid CR Participants will receive a hybrid version of cardiac rehabilitation. | 5 |
| Traditional CR Participants will receive a standard of care version of cardiac rehabilitation. | 5 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Telehealth-enhanced Hybrid CR | Traditional CR | Total |
|---|---|---|---|
| Age, Continuous | 59.1 Years STANDARD_DEVIATION 10.8 | 63.2 Years STANDARD_DEVIATION 12.6 | 61.1 Years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Health-related Quality of Life Score | 78.0 score on a scale STANDARD_DEVIATION 11.2 | 81.3 score on a scale STANDARD_DEVIATION 12.6 | 79.7 score on a scale STANDARD_DEVIATION 11.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 3 Participants | 1 Participants | 4 Participants |
| Region of Enrollment United States | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
| Six Minute Walk Test Distance | 501.7 meters STANDARD_DEVIATION 113.7 | 452.4 meters STANDARD_DEVIATION 133.7 | 477.0 meters STANDARD_DEVIATION 119.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 1 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Mean Proportion of CR Sessions Completed by Participants Allocated to the THCR Intervention
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.
Time frame: Assessed after enrollment (baseline) and until pilot study completion (approximately 12 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Pilot Study Enrollments | Mean Proportion of CR Sessions Completed by Participants Allocated to the THCR Intervention | 0.87 Proportion of CR Sessions Completed | Standard Error 0.13 |
Primary
Number of Participants Who Are Successfully Enrolled Into the Pilot Study Per Month
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.
Time frame: During enrollment, 11 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Pilot Study Enrollments | Number of Participants Who Are Successfully Enrolled Into the Pilot Study Per Month | 0.91 Participants enrolled per month | Standard Error 0.21 |
Secondary
Mean Proportion of CR Sessions Completed by Those Allocated to the Traditional CR Intervention
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.
Time frame: Assessed after enrollment (baseline) and until pilot study completion (approximately 12 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Pilot Study Enrollments | 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
Proportion of Participants That Attend ≥1 CR Session After Randomization in Each Arm
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.
Time frame: During 12-week follow-up period (Up to 12 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Pilot Study Enrollments | Proportion of Participants That Attend ≥1 CR Session After Randomization in Each Arm | 1.00 proportion of participants |
| Traditional CR | Proportion of Participants That Attend ≥1 CR Session After Randomization in Each Arm | 1.00 proportion of participants |
Secondary
Proportion of Participants Who Report Adequate Feasibility of the THCR Intervention
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.
Time frame: At study completion (approximately 12 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Pilot Study Enrollments | Proportion of Participants Who Report Adequate Feasibility of the THCR Intervention | 1.00 Proportion of participants |
Other Pre-specified
Change in Health-related Quality of Life Score
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Pilot Study Enrollments | Change in Health-related Quality of Life Score | 1.3 score on a scale | Standard Error 3.4 |
| Traditional CR | Change in Health-related Quality of Life Score | 7.8 score on a scale | Standard Error 1.1 |
Other Pre-specified
Change in Total Distance Traveled in 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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Pilot Study Enrollments | Change in Total Distance Traveled in 6MWT | 27.12 distance traveled (meters) | Standard Error 8.13 |
| Traditional CR | Change in Total Distance Traveled in 6MWT | 71.10 distance traveled (meters) | Standard Error 10.3 |