Impact of Coronary Images Used During Patient Education on Coronary Artery Disease and Subsequent Lifestyle Modifications. Is a Picture Really Worth a Thousand Words?
Subjects in this research study have Coronary Artery Disease (CAD). This occurs when there is a build-up of fatty material in the wall of the heart arteries that causes narrowing of the arteries. This could lead to chest pain, a heart attack, weakening of the heart and/or permanent damage to the heart. As part of their normal routine care, subjects had or will have a Percutaneous Coronary Intervention (PCI) to restore the blood flow in the arteries of their heart. During a PCI procedure, pictures are taken of the arteries before and after the treatment of the narrowing in the arteries. These pictures are acquired through angiography which is a way to produce X-ray pictures of the inside of arteries.
After a PCI procedure, there is a possibility for narrowing of the arteries to return. The likelihood of this happening can be greatly reduced by lifestyle changes and adhering to heart medication regimens. It is part of normal, routine care for CAD patients to be given written and verbal information on how to lead a heart healthy lifestyle and to take heart medications properly.
In this research study, the investigators will show half of the patients their before and after images of their heart arteries where the narrowing occurred and was treated. The other half of the patients will not be shown these images. Both groups will still receive information about lifestyle and medications as part of their normal, routine care. At the end of this study, the investigators will compare both groups to see if there are any differences in making lifestyle changes and taking heart medications properly. Additionally, the investigators would also like to see if there are any resulting differences in the amount of hearts attacks or other heart related medical events.
|Coronary Artery Disease||Behavioral: Impact of Coronary Images Used During Patient Education on Coronary Artery Disease and Subsequent Lifestyle Modifications|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|Official Title:||Impact of Coronary Images Used During Patient Education on Coronary Artery Disease and Subsequent Lifestyle Modifications. Is a Picture Really Worth a Thousand Words?|
- Significant improvement of patient's knowledge in the group that receives the images versus the group that receives standard education of coronary artery risk factors as measured on questionnaires from baseline to 30 days and at 3 and 6 month follow up [ Time Frame: 6 months ]
- The secondary endpoints of the study is a significant improvement in the patient's adherence to nutritional, exercise and medical regimen in the group receiving the images and education versus the group that receives standard education alone [ Time Frame: 6 months ]
- An exploratory analysis will assess the impact of the aforementioned educational intervention on the occurrence of major adverse cardiovascular events [ Time Frame: 6 months ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
|Experimental: Patients who are shown the images||
Behavioral: Impact of Coronary Images Used During Patient Education on Coronary Artery Disease and Subsequent Lifestyle Modifications
Subjects will be randomly assigned (like the flip of a coin) to a study group. One group will be given before and after treatment pictures of their affected heart arteries. The other group will not be shown these pictures. Both groups will still receive written and verbal information about living a heart healthy lifestyle and taking heart medications properly as part of their normal routine care.
|No Intervention: Patients who are not shown the images|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275716
|Contact: Janet Karol||(773) email@example.com|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Janet Karol 773-834-8399 firstname.lastname@example.org|
|Principal Investigator: Sandeep Nathan, MD|
|Sub-Investigator: Janet Karol, NP|
|Sub-Investigator: Atman Shah, MD|
|Principal Investigator:||Sandeep Nathan, MD||University of Chicago|