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

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Emory University
ClinicalTrials.gov Identifier:
NCT00208832
First received: September 13, 2005
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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 Intervention
Coronary Disease
Procedure: Graphic medication schedule (Pill card)
Procedure: Refill reminder postcard

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind
Official Title: A Randomized Controlled Trial to Improve Medication Compliance Among Patients With Coronary Heart Disease

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Medication Compliance at one year

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

Estimated Enrollment: 440
Study Start Date: March 2004
Estimated Study Completion Date: March 2006
  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208832

Locations
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
American Heart Association
Investigators
Principal Investigator: Sunil Kripalani, MD, MSc Emory University
  More Information

No publications provided

Responsible Party: Emory University
ClinicalTrials.gov Identifier: NCT00208832     History of Changes
Other Study ID Numbers: 0784-2003, AHA 0335119N
Study First Received: September 13, 2005
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Medication Compliance
Health Literacy

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 April 23, 2014