The Healthy Heart Study
Completed · Not applicable
Conditions studied: Cardiac Rehabilitation
In brief
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".
Key facts
- Study ID
- NCT02105246
- Run by
- University of California, San Francisco
- People needed
- 1154
- Starts
- 2015-07-15
- Expected to finish
- 2018-03-31
- Last updated by the study team
- 2019-04-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Post MI, CABG, or PCI Able to speak, read and write in english
You may not qualify if…
- 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
Where it is running
- San Francisco Veterans Affairs Medical Center — San Francisco, California, United States
Full record on ClinicalTrials.gov
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