Readiness for Behavior Change After a Heart Attack (ENROLL)
Stages of Change Through the Cardiac Rehabilitation Experience After a Recent Hospitalization
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Cardiac Rehabilitation is central to full recovery after a myocardial infarction or a cardiac stenting procedure. Yet, this therapy is underutilized across the nation. Henry Ford currently enrolls about 42% of eligible patients. In addition, it currently takes, on average, 42 +/-26 days from hospital discharge to enrollment in rehabilitation. During this delay, there is strong tendency to return to prior habits (sedentary lifestyle, smoking, poor nutrition, etc.) that led to the myocardial infarction in the first place. This delay is both 1) unnecessary and 2) probably harmful to the patients' readiness to make changes.
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Michigan
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Detroit, Michigan, Stati Uniti, 48202
- Henry Ford Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Stable Angina
- Myocardial infarction
- Percutaneous coronary intervention
- willingness to participate and consent for medical record review
- willingness to complete survey's
Exclusion Criteria:
- Recent illicit drug use
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Early Appointment
Patients will receive an early appointment (within 10 days) from the time of their anticipated hospital discharge
|
Patients will receive an appointment to cardiac rehabilitation within 10 days from anticipated hospital discharge.
|
|
Comparatore placebo: 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.
|
Standard Referral to Cardiac Rehabilitation
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Attendance at the free orientation session for Cardiac Rehabilitation
Lasso di tempo: within 5 weeks of randomized apointment date
|
within 5 weeks of randomized apointment date
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Completion of at least one exercise session in Cardiac Rehabilitation
Lasso di tempo: within 1 month of orientation date
|
within 1 month of orientation date
|
|
|
Total number of cardiac rehabilitation exercise sessions attended
Lasso di tempo: within 6 months of actual orientation date
|
within 6 months of actual orientation date
|
|
|
Completion of the cardiac rehabilitation program
Lasso di tempo: within 6 months
|
Completion is defined at attending the number of sessions agreed to at the onset of cardiac rehabilitation (e.g.
agreeing to 3 session and attending 3) or attending 12 or more sessions.
|
within 6 months
|
|
Change in exercise capacity from the beginning to end of cardiac rehabilitation
Lasso di tempo: within 6 months
|
exercise capacity will be calculated from treadmill workloads using standardized formulas published in the 8th edition of ACSM's Guidelines for exercise testing and prescription
|
within 6 months
|
|
Readiness to make positive behavior changes
Lasso di tempo: within 3 months
|
Based on a 10 question survey, each patient will have a summary score to collapse across these questions.
This summary score will be compared at 0, 5, and 13 weeks.
|
within 3 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Quinn R Pack, MD, Henry Ford Hospital
- Direttore dello studio: Steven J Keteyian, PhD, Henry Ford Hospital
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Ischemia
- Processi patologici
- Necrosi
- Ischemia miocardica
- Malattie cardiache
- Malattia cardiovascolare
- Malattie vascolari
- Arteriosclerosi
- Malattie arteriose occlusive
- Dolore
- Manifestazioni neurologiche
- Malattia coronarica
- Dolore al petto
- Angina pectoris
- Infarto miocardico
- Infarto
- Disfunsione dell'arteria coronaria
- Angina, Stabile
Altri numeri di identificazione dello studio
- HFHS 6649
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