Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
150 participants
INTERVENTIONAL
2011-02-28
2012-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The investigators seek to perform a randomized controlled trial of early (7-10 days) vs standard referral (5-6 weeks) to cardiac rehabilitation. In addition, the investigators will examine the patients' readiness to change through the first 3 months of the post-hospitalization period and correlate that to their behavior and enrollment in cardiac rehabilitation. Assessment of readiness to change will be accomplished by serial survey's, which will be administered at discharge, 2 weeks, 5 weeks, and 13 weeks after discharge.
Patients will consent to take the survey and be observed in a clinical study. However, in order to avoid the Hawthorne Effect, patients they will not initially be aware of the primary hypothesis, as the investigators strongly believe this will affect the main behavior they are trying to measure. Full patient disclosure will occur at the end of the trial.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Early Appointment
Patients will receive an early appointment (within 10 days) from the time of their anticipated hospital discharge
Early appointment (within 10 days)
Patients will receive an appointment to cardiac rehabilitation within 10 days from anticipated hospital discharge.
Standard Referral
Patients will receive an appointment to cardiac rehabilitation at 5 weeks from the date of their anticipated hospital discharge. A routine referral to cardiac rehabilitation will also occur in parallel. Consequently, it is possible that some patients will attend cardiac rehabilitation earlier than their assigned 5 week appointment.
Routine referral (at 5 weeks)
Standard Referral to Cardiac Rehabilitation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Early appointment (within 10 days)
Patients will receive an appointment to cardiac rehabilitation within 10 days from anticipated hospital discharge.
Routine referral (at 5 weeks)
Standard Referral to Cardiac Rehabilitation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Myocardial infarction
* Percutaneous coronary intervention
* willingness to participate and consent for medical record review
* willingness to complete survey's
Exclusion Criteria
* Unstable psychiatric condition
* Moderate or severe dementia
* Inability to follow-up
* Leaving system with plans to enroll in cardiac rehabilitation out-of-system
* Inability to exercise (amputee, severe claudication)
* Unstable medical condition that would prevent regular exercise training
* Uncorrected severe aortic stenosis or severe mitral stenosis
* Referring physician feels that exercise is contra-indicated due to safety or other patient specific factors
* CABG, LVAD, or Heart Transplant
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Henry Ford Health System
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Quinn R Pack
Cardiology Fellow
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Quinn R Pack, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Hospital
Steven J Keteyian, PhD
Role: STUDY_DIRECTOR
Henry Ford Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Henry Ford Hospital
Detroit, Michigan, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Balady GJ, Ades PA, Bittner VA, Franklin BA, Gordon NF, Thomas RJ, Tomaselli GF, Yancy CW; American Heart Association Science Advisory and Coordinating Committee. Referral, enrollment, and delivery of cardiac rehabilitation/secondary prevention programs at clinical centers and beyond: a presidential advisory from the American Heart Association. Circulation. 2011 Dec 20;124(25):2951-60. doi: 10.1161/CIR.0b013e31823b21e2. Epub 2011 Nov 14. No abstract available.
Russell KL, Holloway TM, Brum M, Caruso V, Chessex C, Grace SL. Cardiac rehabilitation wait times: effect on enrollment. J Cardiopulm Rehabil Prev. 2011 Nov-Dec;31(6):373-7. doi: 10.1097/HCR.0b013e318228a32f.
Pack QR, Mansour M, Barboza JS, Hibner BA, Mahan MG, Ehrman JK, Vanzant MA, Schairer JR, Keteyian SJ. An early appointment to outpatient cardiac rehabilitation at hospital discharge improves attendance at orientation: a randomized, single-blind, controlled trial. Circulation. 2013 Jan 22;127(3):349-55. doi: 10.1161/CIRCULATIONAHA.112.121996. Epub 2012 Dec 18.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HFHS 6649
Identifier Type: -
Identifier Source: org_study_id