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Readiness for Behavior Change After a Heart Attack (ENROLL)

13. november 2012 oppdatert av: Quinn R Pack, Henry Ford Health System

Stages of Change Through the Cardiac Rehabilitation Experience After a Recent Hospitalization

The purpose of this study is to test if an early appointment (within 10 days) when compared to a standard appointment (5 weeks) will affect attendance at the Cardiac Rehabilitation orientation and subsequent enrollment into cardiac rehabilitation.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Michigan
      • Detroit, Michigan, Forente stater, 48202
        • Henry Ford Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Early Appointment
Patients will receive an early appointment (within 10 days) from the time of their anticipated hospital discharge
Atferdsmessig: Early appointment (within 10 days)
Patients will receive an appointment to cardiac rehabilitation within 10 days from anticipated hospital discharge.
Placebo komparator: 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.
Annen: Routine referral (at 5 weeks)
Standard Referral to Cardiac Rehabilitation

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Attendance at the free orientation session for Cardiac Rehabilitation
Tidsramme: within 5 weeks of randomized apointment date
within 5 weeks of randomized apointment date

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Completion of at least one exercise session in Cardiac Rehabilitation
Tidsramme: within 1 month of orientation date
within 1 month of orientation date
Total number of cardiac rehabilitation exercise sessions attended
Tidsramme: within 6 months of actual orientation date
within 6 months of actual orientation date
Completion of the cardiac rehabilitation program
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Henry Ford Health System

Etterforskere

  • Hovedetterforsker: Quinn R Pack, MD, Henry Ford Hospital
  • Studieleder: Steven J Keteyian, PhD, Henry Ford Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2011

Primær fullføring (Faktiske)

1. juni 2012

Studiet fullført (Faktiske)

1. november 2012

Datoer for studieregistrering

Først innsendt

9. mai 2012

Først innsendt som oppfylte QC-kriteriene

9. mai 2012

Først lagt ut (Anslag)

10. mai 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

14. november 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. november 2012

Sist bekreftet

1. november 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HFHS 6649

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