Readiness for Behavior Change After a Heart Attack (ENROLL)
Stages of Change Through the Cardiac Rehabilitation Experience After a Recent Hospitalization
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Comparador de 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.
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Standard Referral to Cardiac Rehabilitation
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Attendance at the free orientation session for Cardiac Rehabilitation
Prazo: within 5 weeks of randomized apointment date
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within 5 weeks of randomized apointment date
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Completion of at least one exercise session in Cardiac Rehabilitation
Prazo: within 1 month of orientation date
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within 1 month of orientation date
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|
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Total number of cardiac rehabilitation exercise sessions attended
Prazo: within 6 months of actual orientation date
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within 6 months of actual orientation date
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|
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Completion of the cardiac rehabilitation program
Prazo: within 6 months
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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
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Change in exercise capacity from the beginning to end of cardiac rehabilitation
Prazo: within 6 months
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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
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within 6 months
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Readiness to make positive behavior changes
Prazo: within 3 months
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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.
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within 3 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Quinn R Pack, MD, Henry Ford Hospital
- Diretor de estudo: Steven J Keteyian, PhD, Henry Ford Hospital
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Isquemia
- Processos Patológicos
- Necrose
- Isquemia do miocárdio
- Doenças cardíacas
- Doenças cardiovasculares
- Doenças Vasculares
- Arteriosclerose
- Doenças Arteriais Oclusivas
- Dor
- Manifestações Neurológicas
- Doença cardíaca
- Dor no peito
- Angina Pectoris
- Infarto do miocárdio
- Infarte
- Doença arterial coronária
- Angina, Estável
Outros números de identificação do estudo
- HFHS 6649
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Ensaios clínicos em Early appointment (within 10 days)
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