Impact of Coronary Images Used During Patient Education on Coronary Artery Disease and Subsequent Lifestyle Modifications. Is a Picture Really Worth a Thousand Words?

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01275716
First received: January 10, 2011
Last updated: September 4, 2013
Last verified: June 2012
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Behavioral: Impact of Coronary Images Used During Patient Education on Coronary Artery Disease and Subsequent Lifestyle Modifications

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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?

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • An exploratory analysis will assess the impact of the aforementioned educational intervention on the occurrence of major adverse cardiovascular events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Over the age of 18
  2. Able to provide informed consent in English.
  3. Undergoing percutaneous coronary intervention for any clinical indication.

Exclusion Criteria:

  1. Patients not able to provide informed consent.
  2. Patients without a means for telephone communication.
  3. Incarcerated individuals and other special populations.
  4. Patients unable to or unwilling to reliably participate in telephone followup.
  5. Significant neurologic co morbidities such as cerebrovascular accidents with deficit or developmental delays which may impact learning and/or memory
  6. Any medical comorbidity which might result in life-expectancy < 1 year
  7. Any other condition of sufficient severity to impair cooperation in the study- i.e. substance abuse, etc.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275716

Contacts
Contact: Janet Karol (773) 834-8399 jkarol@uchicago.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Janet Karol    773-834-8399    jkarol@uchicago.edu   
Principal Investigator: Sandeep Nathan, MD         
Sub-Investigator: Janet Karol, NP         
Sub-Investigator: Atman Shah, MD         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Sandeep Nathan, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01275716     History of Changes
Other Study ID Numbers: 10-623-A
Study First Received: January 10, 2011
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Patient Education
coronary artery disease
Impact of Coronary Images Used During Patient Education on Coronary Artery Disease and Subsequent Lifestyle Modifications.

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

ClinicalTrials.gov processed this record on August 18, 2014