Skip to main content
OpenTrials
Completed

NCT Number: NCT01596036

Readiness for Behavior Change After a Heart Attack

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myocardial Infarction Angina Pectoris Angina, Stable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stable Angina Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early appointment (within 10 days)

Behavioral

Patients will receive an appointment to cardiac rehabilitation within 10 days from anticipated hospital discharge.

Routine referral (at 5 weeks)

Other

Standard Referral to Cardiac Rehabilitation

Primary outcomes

  1. Attendance at the free orientation session for Cardiac Rehabilitation

    Time frame: within 5 weeks of randomized apointment date

Secondary outcomes

  1. Completion of at least one exercise session in Cardiac Rehabilitation

    Time frame: within 1 month of orientation date

  2. Total number of cardiac rehabilitation exercise sessions attended

    Time frame: within 6 months of actual orientation date

  3. Completion of the cardiac rehabilitation program

    Time frame: 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.

  4. Change in exercise capacity from the beginning to end of cardiac rehabilitation

    Time frame: 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

  5. Readiness to make positive behavior changes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Acronym: ENROLL

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 10, 2012
Registry last updated
Nov 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.