Readiness for Behavior Change After a Heart Attack (ENROLL)
Stages of Change Through the Cardiac Rehabilitation Experience After a Recent Hospitalization
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Michigan
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Detroit, Michigan, États-Unis, 48202
- Henry Ford Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Early Appointment
Patients will receive an early appointment (within 10 days) from the time of their anticipated hospital discharge
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Patients will receive an appointment to cardiac rehabilitation within 10 days from anticipated hospital discharge.
|
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Comparateur 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Attendance at the free orientation session for Cardiac Rehabilitation
Délai: within 5 weeks of randomized apointment date
|
within 5 weeks of randomized apointment date
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Completion of at least one exercise session in Cardiac Rehabilitation
Délai: within 1 month of orientation date
|
within 1 month of orientation date
|
|
|
Total number of cardiac rehabilitation exercise sessions attended
Délai: within 6 months of actual orientation date
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within 6 months of actual orientation date
|
|
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Completion of the cardiac rehabilitation program
Délai: 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.
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within 6 months
|
|
Change in exercise capacity from the beginning to end of cardiac rehabilitation
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Quinn R Pack, MD, Henry Ford Hospital
- Directeur d'études: Steven J Keteyian, PhD, Henry Ford Hospital
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Ischémie
- Processus pathologiques
- Nécrose
- Ischémie myocardique
- Maladies cardiaques
- Maladies cardiovasculaires
- Maladies vasculaires
- Artériosclérose
- Maladies artérielles occlusives
- La douleur
- Manifestations neurologiques
- Maladie coronarienne
- Douleur thoracique
- Angine de poitrine
- Infarctus du myocarde
- Infarctus
- Maladie de l'artère coronaire
- Angine stable
Autres numéros d'identification d'étude
- HFHS 6649
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