Cardiac Rehabilitation
Conditions
Keywords
cardiovascular disease, cardiac rehabilitation, secondary prevention, comparative effectiveness, 6 minute walk test
Brief summary
The long-term goal of this research is to improve patient-centered outcomes in patients with coronary heart disease (CHD), the leading cause of death in the world. Exercise-based cardiac rehabilitation (CR) programs decrease mortality and improve quality of life in patients with CHD. Published guidelines recommend exercise-based CR following hospitalization for myocardial infarction, coronary artery bypass grafting, or percutaneous coronary revascularization. Despite these compelling benefits, CR programs are vastly underutilized, with less than a third of eligible patients participating. One promising solution is greater implementation of home-based CR. Both home and center-based CR programs have equal benefits on cardiovascular risk factors and quality of life. However, similar efficacy does not necessarily translate into similar effectiveness. If patients are more likely to participate in home- vs. center-based therapy, then greater participation could lead to greater clinical effectiveness. We are therefore conducting a quasi-experimental, controlled trial at two VA medical centers to determine the comparative effectiveness of referral to home- vs. center-based CR in patients with CHD. Aim 1: Determine whether automatic referral to home- vs. center-based CR increases patient participation in CR after hospitalization for myocardial infarction or coronary revascularization. Aim 2: Among patients who choose to participate in CR, compare the effectiveness of home- vs. center-based CR on six-minute walk distance, quality of life, and healthcare expenditures. Aim 3: Determine whether the effects of home vs. center-based CR differ by age, gender, race, ethnicity, employment, socioeconomic status, social support, comorbid conditions, or patient preference. Results from this study will (a) help policy makers determine the effect of covering home CR on healthcare expenditures in patients with CHD; (b) help providers understand the potential benefits and harms of home- vs. center-based CR; and (c) help patients answer questions like, Given my personal circumstances and preferences, which of these options will improve the outcomes most important to me.
Detailed description
The long-term goal of this research is to improve patient-centered outcomes in patients with coronary heart disease (CHD). CHD is the leading cause of death in the world. Exercise-based cardiac rehabilitation (CR) programs decrease mortality and improve quality of life in patients with CHD. Published guidelines recommend exercise-based CR following hospitalization for myocardial infarction, coronary artery bypass grafting, or percutaneous coronary revascularization, and referral to CR is one of nine performance measures established by the American Heart Association and American College of Cardiology for patients with CHD. Despite these compelling benefits, CR programs are vastly underutilized, with less than a third of eligible patients participating. The largest barrier to patient participation is that CR must be provided in a physician's office or hospital setting to qualify for reimbursement. For this reason, virtually all existing CR programs require that the patient travel to a CR center 3 times per week for 12 to 36 weeks. Unfortunately, many Americans live too far from a CR center to enroll, and even when nearby programs are available, many patients do not have the time, flexibility, transportation, social support, and/or financial resources to attend. One promising solution to the problem of CR under-utilization is greater implementation of home-based CR. Both home and center-based CR programs have equal benefits on cardiovascular risk factors and quality of life. However, similar efficacy does not necessarily translate into similar effectiveness. If patients are more likely to participate in home- vs. center-based therapy, then greater participation could lead to greater clinical effectiveness. We are therefore conducting a quasi-experimental, controlled trial at two VA medical centers to determine the comparative effectiveness of referral to home- vs. center-based CR in patients with CHD. Aim 1: Determine whether automatic referral to home- vs. center-based CR increases patient participation in CR after hospitalization for myocardial infarction or coronary revascularization. Aim 2: Among patients who choose to participate in CR, compare the effectiveness of home- vs. centerbased CR on six-minute walk distance, quality of life, and healthcare expenditures. Aim 3: Determine whether the effects of home vs. center-based CR differ by age, gender, race, ethnicity, employment, socioeconomic status, social support, comorbid conditions, or patient preference. Results from this study will (a) help policy makers determine the effect of covering home CR on healthcare expenditures in patients with CHD; (b) help providers understand the potential benefits and harms of home- vs. center-based CR; and (c) help patients answer questions like, Given my personal circumstances and preferences, which of these options will improve the outcomes most important to me.
Interventions
Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes.
Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting.
Sponsors
Study design
Eligibility
Inclusion criteria
Post MI, CABG, or PCI Able to speak, read and write in english
Exclusion criteria
Class IV CHF Unstable Angina Complex Ventricular Arrythmias EF \<35% without AICD AICD candidate Resting SBP \>200mmHG Resting DBP\>110mmHG Cognitive Impairment by MoCA Score \<26 Life expectancy \<1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participation in Cardiac Rehabilitation | 12 Months | Number of eligible patients who participated in at least one cardiac rehabilitation exercise session. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Distance Completed on 6-minute Walk Test | 3 months | Baseline to 3-month change in 6-minute walk test distance (feet) among subjects who participated in home-based vs. center-based cardiac rehab. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Home-based Referral to home-based cardiac rehabilitation (intervention): Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes. | 557 |
| Center-based Referral to center-based cardiac rehabilitation (standard of care): Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting. | 597 |
| Total | 1,154 |
Baseline characteristics
| Characteristic | Home-based | Center-based | Total |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 9 | 66 years STANDARD_DEVIATION 10 | 66.5 years STANDARD_DEVIATION 9.5 |
| Race/Ethnicity, Customized Asian | 16 Participants | 3 Participants | 19 Participants |
| Race/Ethnicity, Customized Black | 41 Participants | 40 Participants | 81 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 51 Participants | 4 Participants | 55 Participants |
| Race/Ethnicity, Customized Missing data | 71 Participants | 130 Participants | 201 Participants |
| Race/Ethnicity, Customized White non-Hispanic | 378 Participants | 420 Participants | 798 Participants |
| Region of Enrollment United States | 557 participants | 597 participants | 1154 participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 17 Participants |
| Sex: Female, Male Male | 550 Participants | 587 Participants | 1137 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 231 | 0 / 252 |
| other Total, other adverse events | 0 / 231 | 0 / 252 |
| serious Total, serious adverse events | 0 / 231 | 0 / 252 |
Outcome results
Participation in Cardiac Rehabilitation
Number of eligible patients who participated in at least one cardiac rehabilitation exercise session.
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Referral to Home-based Cardiac Rehabilitation | Participation in Cardiac Rehabilitation | 231 Participants |
| Referral to Center-based Cardiac Rehabilitation | Participation in Cardiac Rehabilitation | 252 Participants |
Change in Distance Completed on 6-minute Walk Test
Baseline to 3-month change in 6-minute walk test distance (feet) among subjects who participated in home-based vs. center-based cardiac rehab.
Time frame: 3 months
Population: This analysis compared 3-month change in 6-minute walk test distance among subjects who participated in home-based vs. center-based cardiac rehab. Data from participants who completed the 3 month follow up visit are presented.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Referral to Home-based Cardiac Rehabilitation | Change in Distance Completed on 6-minute Walk Test | 324 feet |
| Referral to Center-based Cardiac Rehabilitation | Change in Distance Completed on 6-minute Walk Test | 128 feet |
Change in Distance Completed on 6-minute Walk Test
Baseline to 6-month change in 6-minute walk test distance (feet) among patients who participated in home-based vs. center-based cardiac rehab.
Time frame: 6 months
Population: This analysis compares 6-month change in 6-minute walk test distance (feet) among patients who participated in home-based cardiac rehab vs. patients who participated in center-based cardiac rehab.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Referral to Home-based Cardiac Rehabilitation | Change in Distance Completed on 6-minute Walk Test | 315 feet |
| Referral to Center-based Cardiac Rehabilitation | Change in Distance Completed on 6-minute Walk Test | 156 feet |