Ignite Creation Date:
2024-05-05 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00714935
Status:
COMPLETED
Last Update Posted:
2015-11-04
First Post:
2008-07-10
Brief Title:
Shared Decision-making Effects on Cardiac Risk Factor Modification Behavior
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Effects of a Decision Aid for Patients With Coronary Artery Disease on Cardiac Risk Factor Modification Behavior and Health Outcomes
Status:
COMPLETED
Status Verified Date:
2015-11
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:
Decision Aids DA to inform patients about health care options and help them to participate in their care choices are widely advocated The main argument for offering patients a choice is that patients preferences vary and health professionals cannot always know what is best for an individual specially when different outcomes have different benefits and risk profiles The standard modes of treatment for patients with coronary artery disease CAD are coronary artery bypass graft CABG surgery medication and angioplasty All three treatments for CAD work better when combined with cardiac risk factor modification behavior CRFMB CRFMB is important for the general public but it is even more important for people with CAD because people with CAD have more at stake In this RCT study we will evaluate the effectiveness of a CAD-DA with and witout an additional decision counseling program DCP on health outcomes and quality of life to improve enhancement of adherence to cardiac risk modification behavior The CAD-DA is developed by the Ottawa Health Research Institute and Division of Clinical Epidemiology at Montreal General Hospital for CAD patients facing the decision of making lifestyle changes to lower their cardiac risk factors It provides patients with information about what they can you do to prevent the disease from progressing The DCP is designed to systematically guide patients through the process of deciding what cardiac risk modification behaviors are important for them to carry out A RCT where 360 CAD patients 18 of age scheduled for an angiogram at Rikshospitalet University Hospital in Norway RH will be randomly assigned to 1 CAD-DA group where subjects will receive for take home the CAD-DA prior to their scheduled angiogram 2 DCP group where subjects in addition to the CAD-DA will receive an individual decisional counseling program DCP from a trained nurse counselor in their homes prior to their angiogram and 3 the control group who will receive usual care Data will be collected at four points at the initial visit T1 2 months T2 4 months T3 and 6 T4 months after angiogram
Detailed Description:
As above
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