Cardiac RehabilitationNCT02105246
The Healthy Heart Study
A study testing Referral to home-based cardiac rehab and Referral to center-based cardiac rehab in people with Cardiac Rehabilitation, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- Referral to home-based cardiac rehab and Referral to center-based cardiac rehab
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,154 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2015to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post MI, CABG, or PCI Able to speak, read and write in english
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94116
About this study
Official title: Improving Delivery of Patient-Centered Cardiac Rehabilitation
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.
Read more
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".
Read the 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.
- Conditions
- Cardiac Rehabilitation
- Being tested
- Referral to home-based cardiac rehab, Referral to center-based cardiac rehab
- Keywords
- cardiovascular disease, cardiac rehabilitation, secondary prevention, comparative effectiveness, 6 minute walk test
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral to home-based cardiac rehabBehavioural
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 rehabBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-based | Experimental | Referral to a home-based cardiac rehabilitation program (intervention). Receives: Behavioral: Referral to center-based cardiac rehab |
| Center-based | Active comparator | Referral to a center-based cardiac rehabilitation program (standard of care). Receives: Behavioral: Referral to home-based cardiac rehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation in Cardiac Rehabilitation
Number of eligible patients who participated in at least one cardiac rehabilitation exercise session.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study start15 Jul 2015
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Mary Whooley, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105246
- Sponsor's protocol ID
- CHR13-10887
- Status last verified
- Jan 2019
- First submitted
- 2 Apr 2014
- Last updated
- 1 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 32954885
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Delivery of Patient-Centered Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT02105246
- Acronym / sponsor ID
- CHR13-10887
- Conditions
- Cardiac Rehabilitation
- Keywords
- cardiovascular disease, cardiac rehabilitation, secondary prevention, comparative effectiveness, 6 minute walk test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,154 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 15 Jul 2015 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Posted 1 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based | Experimental | Behavioral: Referral to center-based cardiac rehabReferral to a home-based cardiac rehabilitation program (intervention). |
| Center-based | Active comparator | Behavioral: Referral to home-based cardiac rehabReferral to a center-based cardiac rehabilitation program (standard of care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Post MI, CABG, or PCI Able to speak, read and write in english
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Referral to home-based cardiac rehabHome-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes. | Behavioural | Center-based |
| Referral to center-based cardiac rehabCenter-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. | Behavioural | Home-based |
Primary outcome
Participation in Cardiac Rehabilitation
Time frame: 12 Months
Number of eligible patients who participated in at least one cardiac rehabilitation exercise session.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32954885Schopfer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Whooley, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Referral to home-based cardiac rehab and Referral to center-based cardiac rehab in people with Cardiac Rehabilitation, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation in Cardiac Rehabilitation (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02105246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.