Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250913
Status:
COMPLETED
Last Update Posted:
2010-11-09
First Post:
2005-11-07
Brief Title:
The Efficacy and Cost-Effectiveness of Behavioral Counseling for Exercise in Men and Women Following Acute Myocardial Infarction AMI and Percutaneous Coronary Intervention PCI
Sponsor:
Ottawa Heart Institute Research Corporation
Organization:
Ottawa Heart Institute Research Corporation
Study Overview
Official Title:
Efficacy and Cost-Effectiveness of Behavioral Counseling For Exercise Behavior in Men and Women Following AMI and PCI
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
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 ie 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 visits with your cardiologist andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None