A Randomized Controlled Trial to Improve Medication Compliance Among Patients With Coronary Heart Disease
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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
- to learn more about the relationship between low health literacy and medication compliance, and
- 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 Primary Purpose: Educational/Counseling/Training |
| Official Title: | A Randomized Controlled Trial to Improve Medication Compliance Among Patients With Coronary Heart Disease |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| United States, Georgia | |
| Grady Memorial Hospital | |
| Atlanta, Georgia, United States, 30303 | |
| Principal Investigator: | Sunil Kripalani, MD, MSc | Emory University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00208832 History of Changes |
| Other Study ID Numbers: | AHA 0335119N |
| Study First Received: | September 13, 2005 |
| Last Updated: | November 13, 2006 |
| 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 May 22, 2013