Study Results
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View full resultsBasic Information
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COMPLETED
NA
1154 participants
INTERVENTIONAL
2015-07-15
2018-03-31
Brief Summary
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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".
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Home-based
Referral to a home-based cardiac rehabilitation program (intervention).
Referral to center-based cardiac rehab
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.
Center-based
Referral to a center-based cardiac rehabilitation program (standard of care).
Referral to home-based cardiac rehab
Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes.
Interventions
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Referral to home-based cardiac rehab
Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes.
Referral to center-based cardiac rehab
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Mary Whooley, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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San Francisco Veterans Affairs Medical Center
San Francisco, California, United States
Countries
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References
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Schopfer DW, Whooley MA, Allsup K, Pabst M, Shen H, Tarasovsky G, Duvernoy CS, Forman DE. Effects of Home-Based Cardiac Rehabilitation on Time to Enrollment and Functional Status in Patients With Ischemic Heart Disease. J Am Heart Assoc. 2020 Oct 20;9(19):e016456. doi: 10.1161/JAHA.120.016456. Epub 2020 Sep 21.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CHR13-10887
Identifier Type: -
Identifier Source: org_study_id
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