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

September 13, 2005
September 21, 2005
December 19, 2013
March 2004
Not Provided
Medication Compliance at one year
Same as current
Complete list of historical versions of study NCT00208832 on Archive Site
Improved blood pressure, cholesterol, and diabetic control at one year
Same as current
Not Provided
Not Provided
A Randomized Controlled Trial to Improve Medication Compliance Among Patients With Coronary Heart Disease
A Randomized Controlled Trial to Improve Medication Compliance Among Patients With Coronary Heart Disease

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.

Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Coronary Disease
  • Procedure: Graphic medication schedule (Pill card)
  • Procedure: Refill reminder postcard
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
AHA 0335119N ( Other Identifier: Other )
Not Provided
Not Provided
Not Provided
Emory University
Emory University
American Heart Association
Principal Investigator: Sunil Kripalani, MD, MSc Emory University
Emory University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP