Working… Menu

A Randomized Controlled Trial to Improve Medication Compliance Among Patients With Coronary Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00208832
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : December 19, 2013
American Heart Association
Information provided by (Responsible Party):
Emory University

Brief Summary:

Coronary heart disease (CHD) is the most common cause of death in the United States. A common term for CHD is "blocked arteries." People with CHD or "blocked arteries" often have high blood pressure, high cholesterol, or diabetes. They are also more likely to suffer a heart attack. Many heart attacks could be prevented by taking medicines that control blood pressure, cholesterol, and diabetes. However, only 50%-60% of patients take their medicines as directed. Patients who don't take their medicines regularly are considered noncompliant.

One of the risk factors for noncompliance is low health literacy. Health literacy is the ability to obtain, understand, and act on basic health information. Patients with low health literacy may not understand their illnesses as well, or how to take their medicines properly.

The purposes of this project are

  1. to learn more about the relationship between low health literacy and medication compliance, and
  2. to test 2 different strategies designed to help patients take their medicines more regularly.

Patients with CHD were recruited when they arrived for a regular doctor's appointment. We measured their health literacy skills, asked questions about how they take their medications, and checked their blood pressure and last cholesterol and diabetes measurements. We then assigned patients to 1 of 4 intervention groups (intervention ongoing). The first group is receiving usual care, which includes regular medication instructions printed on the bottle and no reminders to refill medicines. The second group gets monthly postcards reminding them to refill their prescriptions. The third group gets a new medication schedule that shows them, with pictures and figures, how they are supposed to take their medicines each day. The fourth group receives both the postcards and the new medication schedule. We are following patients for 1 year to see which intervention has the greatest impact on their medication compliance, blood pressure, cholesterol, and diabetes measurements. We will also examine whether patients' health literacy affects the success of the interventions.

Condition or disease Intervention/treatment Phase
Coronary Disease Procedure: Graphic medication schedule (Pill card) Procedure: Refill reminder postcard Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Official Title: A Randomized Controlled Trial to Improve Medication Compliance Among Patients With Coronary Heart Disease
Study Start Date : March 2004
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Medication Compliance at one year

Secondary Outcome Measures :
  1. Improved blood pressure, cholesterol, and diabetic control at one year

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Coronary heart disease, demonstrated by documentation of > 30% stenosis of one or more coronary vessels on cardiac catheterization, history of coronary artery bypass graft surgery, history of angioplasty, or documented myocardial infarction.

Exclusion Criteria:

  • Current participation in another medication adherence study
  • Too ill
  • Does not manage their own medications
  • No mailing address or telephone number
  • Routine prescriptions filled outside of the Grady pharmacy system
  • Psychiatric illnesses, overt delirium or dementia
  • Visual acuity worse than 20/60
  • Unable to communicate in English
  • Already using a medication pill card

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00208832

Layout table for location information
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
American Heart Association
Layout table for investigator information
Principal Investigator: Sunil Kripalani, MD, MSc Emory University

Layout table for additonal information
Responsible Party: Emory University Identifier: NCT00208832     History of Changes
Other Study ID Numbers: 0784-2003
AHA 0335119N ( Other Identifier: Other )
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013
Keywords provided by Emory University:
Medication Compliance
Health Literacy
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases