The Efficacy and Cost-Effectiveness of Behavioral Counseling for Exercise in Men and Women Following Acute Myocardial Infarction (AMI) and Percutaneous Coronary Intervention (PCI)
Condition: Coronary Arteriosclerosis; Myocardial Infarction
MeSH terms: Myocardial Infarction; Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia; Infarction
Study type: Interventional
Phase: Phase 1

Summary: 
      Purpose: The purpose of this project is to determine how effective the telephone-based
      counseling program is at helping patients with heart disease become more physically active.

      Hypotheses to be tested:

        -  Compared to usual care, patients in the physical activity counseling program will:

             1. significantly increase total distance measured by an accelerometer and minutes of
                physical activity at a moderate intensity or higher,

             2. have significantly higher generic and heart-disease health-related quality of life,
                and

             3. will lead to greater improvements in the mediators of behavior change (psychosocial
                variables, i.e. self-efficacy, outcome expectations, etc.) at 26 and 52 weeks;

        -  Changes in the mediators of physical activity will predict changes in physical activity
           outcomes at 26 and 52 weeks;

        -  The physical activity counseling program is preferable to usual care from the
           perspective of health care system costs.
    

Detailed description: 
      Most existing cardiac rehabilitation programs have little ability to expand participation
      using traditional delivery models that emphasize supervised, facility-based programs.
      Furthermore, facility-based programs to promote physical activity behavior in patients with
      coronary artery disease (CAD) are limited in their impact because most patients are unwilling
      to travel more than 30-45 minutes to participate in a program. The University of Ottawa Heart
      Institute Prevention and Rehabilitation Centre (Ottawa, Canada) has developed a
      telephone-based counseling program, specifically to support heart patients in becoming more
      physically active. The study will involve patients either participating in a 12-month
      physical activity counseling (PAC) program, or receiving usual care after they are discharged
      from hospital. For patients assigned to the PAC group, a face-to-face meeting with a physical
      activity counselor will occur within 10 days to 2 weeks after being discharged from hospital.
      At this time the patient will be provided with a personalized physical activity program which
      will be tailored based on prior activity levels, clinical history, and recovery. The PAC
      patients will also receive eight telephone-based counseling sessions at 2, 4, 8, 14, 20 and
      24 weeks, and 2 telephone maintenance contacts at 40 and 52 weeks after hospital discharge.
      Each telephone call is scheduled to last 10-15 minutes. For patients assigned to the usual
      care (UC) group, they will receive the physical activity advice and care usually provided to
      patients discharged from hospital. Following hospitalization, usual care typically includes a
      follow-up visit(s) with your cardiologist and/or family doctor. If requested, an activity
      program will be provided to usual care group participants after the study has finished. In
      addition, the patients will also be required to complete five research questionnaires, and
      two telephone interviews. The study will track all participants for a period of one year from
      the time they are discharged from hospital. Over the next twelve months 252 patients from the
      Ottawa Heart Institute are expected to take part in the study.
    

Intervention name(s): Telephone-based physical activity counseling program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: motor activity; determinants; psychology; health care costs; quality of life; Angioplasty