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

NCT00208832 | Completed

• 2 other identifiers: 0784-2003AHA 0335119N
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Disease

Keywords

Medication Compliance; Health Literacy

Outcome Measures

Primary Outcomes (1)

• Medication Compliance at one year

Secondary Outcomes (1)

• Improved blood pressure, cholesterol, and diabetic control at one year

Interventions

Graphic medication schedule (Pill card) PROCEDURE

Refill reminder postcard PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• American Heart Association: collaborator

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Coronary Disease; Medication Adherence

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Sunil Kripalani, MD, MSc

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: March 1, 2004
• Study Completion: March 1, 2006
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

US (1)