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The Healthy Heart Study
NA trial testing Referral to home-based cardiac rehab in Cardiac Rehabilitation in 1,154 participants. Completed in 31 March 2018.
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 1,154 |
| Start date | 15 July 2015 |
| Primary completion | 31 March 2018 |
| Estimated completion | 31 March 2018 |
| Sites | 1 location across United States |
University of California, San Francisco
18 and older, any sex, with Cardiac Rehabilitation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of eligible patients who participated in at least one cardiac rehabilitation exercise session.
| Group | Value | 95% CI |
|---|---|---|
| Referral to Home-based Cardiac Rehabilitation | 231 | |
| Referral to Center-based Cardiac Rehabilitation | 252 |
Baseline to 3-month change in 6-minute walk test distance (feet) among subjects who participated in home-based vs. center-based cardiac rehab.
| Group | Value | 95% CI |
|---|---|---|
| Home-based Cardiac Rehabilitation Participants | 324 | 160 – 544 |
| Center-based Cardiac Rehabilitation Participants | 128 | 20 – 226 |
Baseline to 6-month change in 6-minute walk test distance (feet) among patients who participated in home-based vs. center-based cardiac rehab.
| Group | Value | 95% CI |
|---|---|---|
| Referral to Home-based Cardiac Rehab | 315 | 60 – 544 |
| Referral to Center-based Cardiac Rehab | 156 | 56 – 305 |
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".
1 peer-reviewed publication reference this trial (live from Europe PMC):
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