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The Healthy Heart Study

Improving Delivery of Patient-Centered Cardiac Rehabilitation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02105246
Enrollment
1154
Registered
2014-04-07
Start date
2015-07-15
Completion date
2018-03-31
Last updated
2019-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Rehabilitation

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

BEHAVIORALReferral 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.

BEHAVIORALReferral 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.

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Participation in Cardiac Rehabilitation12 MonthsNumber of eligible patients who participated in at least one cardiac rehabilitation exercise session.

Other

MeasureTime frameDescription
Change in Distance Completed on 6-minute Walk Test3 monthsBaseline 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

ArmCount
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
Total1,154

Baseline characteristics

CharacteristicHome-basedCenter-basedTotal
Age, Continuous67 years
STANDARD_DEVIATION 9
66 years
STANDARD_DEVIATION 10
66.5 years
STANDARD_DEVIATION 9.5
Race/Ethnicity, Customized
Asian
16 Participants3 Participants19 Participants
Race/Ethnicity, Customized
Black
41 Participants40 Participants81 Participants
Race/Ethnicity, Customized
Hispanic/Latino
51 Participants4 Participants55 Participants
Race/Ethnicity, Customized
Missing data
71 Participants130 Participants201 Participants
Race/Ethnicity, Customized
White non-Hispanic
378 Participants420 Participants798 Participants
Region of Enrollment
United States
557 participants597 participants1154 participants
Sex: Female, Male
Female
7 Participants10 Participants17 Participants
Sex: Female, Male
Male
550 Participants587 Participants1137 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2310 / 252
other
Total, other adverse events
0 / 2310 / 252
serious
Total, serious adverse events
0 / 2310 / 252

Outcome results

Primary

Participation in Cardiac Rehabilitation

Number of eligible patients who participated in at least one cardiac rehabilitation exercise session.

Time frame: 12 Months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Referral to Home-based Cardiac RehabilitationParticipation in Cardiac Rehabilitation231 Participants
Referral to Center-based Cardiac RehabilitationParticipation in Cardiac Rehabilitation252 Participants
Comparison: Null hypothesis = no difference in proportion of patients who participate in cardiac rehab after referral to home-based vs. facility-based programsp-value: 0.8Chi-squared
Other Pre-specified

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.

ArmMeasureValue (MEDIAN)
Referral to Home-based Cardiac RehabilitationChange in Distance Completed on 6-minute Walk Test324 feet
Referral to Center-based Cardiac RehabilitationChange in Distance Completed on 6-minute Walk Test128 feet
Comparison: Null hypothesis: 3-month change in 6MWT distance is not inferior among participants enrolled in home-based vs. facility-based cardiac rehab.p-value: <0.001Wilcoxon (Mann-Whitney)
Other Pre-specified

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.

ArmMeasureValue (MEDIAN)
Referral to Home-based Cardiac RehabilitationChange in Distance Completed on 6-minute Walk Test315 feet
Referral to Center-based Cardiac RehabilitationChange in Distance Completed on 6-minute Walk Test156 feet
Comparison: Null hypothesis: 6-month change in 6MWT distance is not inferior among participants enrolled in home-based vs. facility-based cardiac rehab.p-value: 0.03Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026