The Efficacy and Cost-Effectiveness of Behavioral Counseling for Exercise in Men and Women Following Acute Myocardial Infarction (AMI) and Percutaneous Coronary Intervention (PCI)

Myocardial Infarction Clinical Trial

Official title: Efficacy and Cost-Effectiveness of Behavioral Counseling For Exercise Behavior in Men and Women Following AMI and PCI

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

• NCT number: NCT00250913
• Study type: Interventional
• Source: Ottawa Heart Institute Research Corporation
• Status: Completed
• Phase: Phase 1
• Start date: August 2005
• Completion date: December 2009