Readiness for Behavior Change After a Heart Attack

NCT01596036 | Completed

• 1 other identifier: HFHS 6649
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myocardial Infarction; Stable Angina; Coronary Artery Disease

Keywords

cardiac rehabilitation; referral; enrollment; timing

Outcome Measures

Primary Outcomes (1)

• Attendance at the free orientation session for Cardiac Rehabilitation

  within 5 weeks of randomized apointment date

Secondary Outcomes (5)

• Completion of at least one exercise session in Cardiac Rehabilitation

  within 1 month of orientation date

• Total number of cardiac rehabilitation exercise sessions attended

  within 6 months of actual orientation date

• Completion of the cardiac rehabilitation program

  within 6 months

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

  within 6 months

• Readiness to make positive behavior changes

  within 3 months

Study Arms (2)

Early Appointment

EXPERIMENTAL

Patients will receive an early appointment (within 10 days) from the time of their anticipated hospital discharge

Behavioral: Early appointment (within 10 days)

Standard Referral

PLACEBO COMPARATOR

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)

Interventions

Early appointment (within 10 days) BEHAVIORAL

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

Early Appointment

Routine referral (at 5 weeks) OTHER

Standard Referral to Cardiac Rehabilitation

Standard Referral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable Angina
• Myocardial infarction
• Percutaneous coronary intervention
• willingness to participate and consent for medical record review
• willingness to complete survey's

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (3)

• 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.

  PMID: 22082676 BACKGROUND

• 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.

  PMID: 21826016 BACKGROUND

• 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.

  PMID: 23250992 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Angina, Stable; Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Quinn R Pack, MD

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

• Steven J Keteyian, PhD

  Henry Ford Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Fellow

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 10, 2012
• Study Start: February 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

US (1)