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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00250913
Recruitment Status : Completed
First Posted : November 8, 2005
Last Update Posted : November 9, 2010
Heart and Stroke Foundation of Ontario
Information provided by:
Ottawa Heart Institute Research Corporation

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:

    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.

Condition or disease Intervention/treatment Phase
Coronary Arteriosclerosis Myocardial Infarction Behavioral: Telephone-based physical activity counseling program Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Efficacy and Cost-Effectiveness of Behavioral Counseling For Exercise Behavior in Men and Women Following AMI and PCI
Study Start Date : August 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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+
  2. 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
  3. Primary outcomes measured at baseline and 6 and 12 months

Secondary Outcome Measures :
  1. Psychosocial and Environmental Mediators (questionnaire): psychosocial and environmental mediators of physical activity
  2. Quality of Life (questionnaire): heart disease health-related quality of life
  3. generic quality of life
  4. secondary outcomes measured at baseline and 6 and 12 months
  5. 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)
  6. the use of health care resources will be measured for medical event updates, patient related costs and work absenteeism
  7. cost utility analysis to assess for cost per quality-adjusted life year (QALY)
  8. measured at 3 (telephone), 6 (questionnaire), 9 (telephone) and 12 (questionnaire) months

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00250913

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Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Heart and Stroke Foundation of Ontario
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Principal Investigator: Robert Reid, PhD, MBA Ottawa Heart Institute Research Corporation
Study Chair: Louise Morrin, RPT, MBA Ottawa Heart Institute Research Corporation
Study Chair: Lyall Higginson, MD, FRCP(C) Ottawa Heart Institute Research Corporation
Study Chair: Andrew Pipe, MD The University of Ottawa Heart Institute
Study Chair: Andreas Wielgosz, MD, FRCP(C) The Ottawa General Hospital - Department of Cadiology - General Campus
Study Chair: Neil Oldridge, PhD College of Health Sciences, University of Wisconsin-Milwaukee
Study Chair: George Wells, PhD Clinical Epidemiology Unit, University of Ottawa Heart Institute
Study Chair: Chris Blanchard, PhD Department of Human Kinetics, University of Ottawa & University of Ottawa Heart Institute

Drummond M, O'Brien BJ, Stoddart G, Torrance G. Methodsfor the Economic Evaluation of Health Care Programmes:Oxford Medical Publications; 1997.
Centres for Disease Control. Physical activity and health: Areport of the Surgeon General. Atlanta: National Centre forChronic Disease Prevention and Health Promotion; 1999.

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Responsible Party: Dr. Robert Reid, Univeristy of Ottawa Heart Insitute Identifier: NCT00250913     History of Changes
Other Study ID Numbers: NA 5626
First Posted: November 8, 2005    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: November 2010

Keywords provided by Ottawa Heart Institute Research Corporation:
motor activity
health care costs
quality of life

Additional relevant MeSH terms:
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Myocardial Infarction
Coronary Artery Disease
Myocardial Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Coronary Disease