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Readiness for Behavior Change After a Heart Attack (ENROLL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Quinn R Pack, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01596036
First received: May 9, 2012
Last updated: November 13, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Myocardial Infarction
Stable Angina
Coronary Artery Disease
 Behavioral: Early appointment (within 10 days)
Other: Routine referral (at 5 weeks)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Stages of Change Through the Cardiac Rehabilitation Experience After a Recent Hospitalization

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Attendance at the free orientation session for Cardiac Rehabilitation [ Time Frame: within 5 weeks of randomized apointment date ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Completion of at least one exercise session in Cardiac Rehabilitation [ Time Frame: within 1 month of orientation date ] [ Designated as safety issue: No ]
  • Total number of cardiac rehabilitation exercise sessions attended [ Time Frame: within 6 months of actual orientation date ] [ Designated as safety issue: No ]
  • Completion of the cardiac rehabilitation program [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
    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.

  • Change in exercise capacity from the beginning to end of cardiac rehabilitation [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
    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

  • Readiness to make positive behavior changes [ Time Frame: within 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 150
Study Start Date: February 2011
Study Completion Date: November 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early Appointment
Patients will receive an early appointment (within 10 days) from the time of their anticipated hospital discharge
 Behavioral: Early appointment (within 10 days)
Patients will receive an appointment to cardiac rehabilitation within 10 days from anticipated hospital discharge.
Placebo Comparator: 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.
 Other: Routine referral (at 5 weeks)
Standard Referral to Cardiac Rehabilitation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596036

Locations
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Quinn R Pack, MD Henry Ford Hospital
Study Director: Steven J Keteyian, PhD Henry Ford Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Quinn R Pack, Cardiology Fellow, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01596036     History of Changes
Other Study ID Numbers: HFHS 6649
Study First Received: May 9, 2012
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
cardiac rehabilitation
referral
enrollment
timing

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on June 18, 2013