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

Study Overview
=================
Brief 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: significantly increase total distance measured by an accelerometer and minutes of physical activity at a moderate intensity or higher, have significantly higher generic and heart-disease health-related quality of life, and 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.

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

Conditions
-----------------
Coronary Arteriosclerosis, Myocardial Infarction

Intervention / Treatment
-----------------
* Behavioral: Telephone-based physical activity counseling program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac Diagnosis: 1) hospitalized patients ready for discharge following successful PCI procedure Including patients receiving PCI following admission for AMI or hospitalized post-AMI patients who have not been revascularized No lesions with >50 % stenosis English proficiency in reading, writing and speaking Age: 20-85 years Exclusion Criteria: Those patients who are already taking part in another research trial. Patient intends to enroll, or is currently enrolled in structured cardiac rehabilitation Unable to participate in the on-site cardiac supervised rehab program, cardiac rehab lite, case-managed home cardiac rehab program, Pembroke cardiac rehab program Hospitalization for coronary artery bypass (CABG) Chronic obstructive pulmonary disease (COPD) Hospitalization for diagnostic procedure not associated with previously documented MI Patient coming back to hospital for planned staged PCI within 6 months Cardiac transplantation Presence of, or hospitalization for defibrillator implant Hospitalization for pacemaker implantation Unresolved unstable angina and/or hospitalization for angina (without MI or PCI) Uncontrolled arrhythmias causing symptoms or hemodynamic compromise Neuromuscular, musculoskeletal or rheumatoid disorders that are exacerbated by exercise Other uncontrolled metabolic conditions (e.g. diabetes) Chronic infectious diseases such as mononucleosis, hepatitis, AIDS Acute systemic illness or fever Uncontrolled tachycardia (<120 bpm) Uncompensated congestive heart failure (and/or NYHA Class III, or IV) 3rd degree atrioventricular (AV) block (without pacemaker) Active pericarditis or myocarditis Recent embolism Suspected or known abdominal aortic aneurysm (AAA) > 4cm Uncontrolled hypertension (systolic blood pressure [SBP] >200; diastolic blood pressure [DBP] >110) Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Telephone-based physical activity counseling program|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day physical activity levels: waist mounted pedometer will be worn to measure distance (km) over a period of 9 days and will be recorded in an activity log, as well as, reported intensity and duration of activities at a moderate level+ |  |  | 
| 7-day physical activity recall (PAR): interview administered following the pedometer wear to verify the completeness of the patient recorded activity log and to account for leisure and occupational/domestic activities |  |  | 
| Primary outcomes measured at baseline and 6 and 12 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial and Environmental Mediators (questionnaire): psychosocial and environmental mediators of physical activity |  |  | 
| Quality of Life (questionnaire): heart disease health-related quality of life |  |  | 
| generic quality of life |  |  | 
| secondary outcomes measured at baseline and 6 and 12 months |  |  | 
| Health Care Systems Costs (questionnaire and telephone): the costs of in-person and telephone-based behavioral counseling sessions and any additional health care relating to coronary artery disease (CAD) |  |  | 
| the use of health care resources will be measured for medical event updates, patient related costs and work absenteeism |  |  | 
| cost utility analysis to assess for cost per quality-adjusted life year (QALY) |  |  | 
| measured at 3 (telephone), 6 (questionnaire), 9 (telephone) and 12 (questionnaire) months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
motor activity, determinants, psychology, health care costs, quality of life, Angioplasty