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Sponsors and Collaborators: |
University of Ottawa Heart Institute Heart and Stroke Foundation of Ontario |
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Information provided by: | University of Ottawa Heart Institute |
ClinicalTrials.gov Identifier: | NCT00250913 |
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:
self-efficacy, outcome expectations, etc.) at 26 and 52 weeks;
Condition | Intervention | Phase |
---|---|---|
Coronary Arteriosclerosis Myocardial Infarction |
Behavioral: Telephone-based physical activity counseling program |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Efficacy and Cost-Effectiveness of Behavioral Counseling For Exercise Behavior in Men and Women Following AMI and PCI |
Estimated Enrollment: | 304 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 20 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Cardiac Diagnosis:
1) hospitalized patients ready for discharge following successful PCI procedure
Exclusion Criteria:
Contact: Chantal R Nelson, BSc, MPH | (613) 798-5555 ext 17879 | cnelson@ottawaheart.ca |
Contact: Robert Reid, PhD, MBA | (613) 761-5058 | BReid@ottawaheart.ca |
Canada, Ontario | |
University of Ottawa Heart Institute | Recruiting |
Ottawa, Ontario, Canada, K1Y 4W7 | |
Contact: Chantal R Nelson, BSc, MPH (613) 798-5555 ext 17879 cnelson@ottawaheart.ca | |
Contact: Robert Reid, PhD, MBA 613-761-5058 BReid@ottawaheart.ca | |
Principal Investigator: Robert Reid, PhD, MBA |
Principal Investigator: | Robert Reid, PhD, MBA | University of Ottawa Heart Institute |
Study Chair: | Louise Morrin, RPT, MBA | University of Ottawa Heart Institute |
Study Chair: | Lyall Higginson, MD, FRCP(C) | University of Ottawa Heart Institute |
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 |
Responsible Party: | Univeristy of Ottawa Heart Insitute ( Dr. Robert Reid ) |
Study ID Numbers: | NA 5626 |
Study First Received: | November 7, 2005 |
Last Updated: | March 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00250913 History of Changes |
Health Authority: | Canada: Health Canada; United States: Institutional Review Board |
motor activity determinants psychology |
health care costs quality of life Angioplasty |
Arterial Occlusive Diseases Coronary Disease Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Quality of Life Ischemia Arteriosclerosis Infarction Myocardial Infarction Coronary Artery Disease |
Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Vascular Diseases Arteriosclerosis Ischemia Coronary Disease |
Necrosis Pathologic Processes Cardiovascular Diseases Infarction Myocardial Infarction Coronary Artery Disease |