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The Healthy Heart Study

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ClinicalTrials.gov Identifier: NCT02105246
Recruitment Status : Completed
First Posted : April 7, 2014
Results First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of California, San Francisco

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".


Condition or disease Intervention/treatment Phase
Cardiac Rehabilitation Behavioral: Referral to home-based cardiac rehab Behavioral: Referral to center-based cardiac rehab Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1154 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Delivery of Patient-Centered Cardiac Rehabilitation
Actual Study Start Date : July 15, 2015
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Home-based
Referral to a home-based cardiac rehabilitation program (intervention).
Behavioral: 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.

Active Comparator: Center-based
Referral to a center-based cardiac rehabilitation program (standard of care).
Behavioral: 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.




Primary Outcome Measures :
  1. Participation in Cardiac Rehabilitation [ Time Frame: 12 Months ]
    Number of eligible patients who participated in at least one cardiac rehabilitation exercise session.


Other Outcome Measures:
  1. Change in Distance Completed on 6-minute Walk Test [ Time Frame: 3 months ]
    Baseline to 3-month change in 6-minute walk test distance (feet) among subjects who participated in home-based vs. center-based cardiac rehab.

  2. Change in Distance Completed on 6-minute Walk Test [ Time Frame: 6 months ]
    Baseline to 6-month change in 6-minute walk test distance (feet) among patients who participated in home-based vs. center-based cardiac rehab.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105246


Locations
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United States, California
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States, 94116
Sponsors and Collaborators
University of California, San Francisco
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Mary Whooley, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02105246     History of Changes
Other Study ID Numbers: CHR13-10887
First Posted: April 7, 2014    Key Record Dates
Results First Posted: April 1, 2019
Last Update Posted: April 1, 2019
Last Verified: January 2019
Keywords provided by University of California, San Francisco:
cardiovascular disease
cardiac rehabilitation
secondary prevention
comparative effectiveness
6 minute walk test