Trial record 3 of 85 for:    angina OR chest pain OR acute coronary syndrome | Open Studies | NIH, U.S. Fed

Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes (IMAGE-ACS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
American Society of Health-System Pharmacists Research and Education Foundation
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00399880
First received: November 13, 2006
Last updated: June 15, 2009
Last verified: November 2006
  Purpose

Coronary heart disease (CHD) is the leading cause of death in the United States. Most people who die from CHD die of a heart attack. Acute coronary syndrome (ACS) is a term that includes mild heart attacks, as well as other episodes of chest pain that may serve as a warning sign for an upcoming heart attack.

There are many medicines that can help prevent and treat ACS. However, at least 25% of patients don't take their medications as prescribed. When patients don't take their medications, we say they are noncompliant or nonadherent with the treatment.

The period following hospital discharge is a vulnerable time for many patients. Patients are often confused about what to do when they return home from the hospital. Many patients don,t take their medications correctly, or they don't take them at all. Patients with poor literacy skills have more trouble than others, because it is harder for them to follow written instructions. Overall, about half of the adults in the U.S. have poor literacy skills. It is important to develop ways to help these adults manage their health better.

The purposes of this research project are 1) to learn more about the relationship between low literacy and medication adherence after hospital discharge, and 2) to test a strategy designed to help patients take their medicines more regularly. We will recruit consenting patients hospitalized with ACS. We will measure their literacy skills, ask questions about how they take their medicines, and measure other related factors like social support and self-efficacy. Patients will then be assigned to 1 of 2 groups. One group will receive only usual care at hospital discharge, which usually includes the nurse and physician briefly reviewing the medication prescriptions. The other group will receive an illustrated daily medication schedule and special, tailored counseling from a pharmacist at their time of discharge. About 1 week after patients leave the hospital we will contact them by phone to ask them questions about how they have been taking their medicines. We will get data from patients records for 6 months to see if the intervention had an impact on their medication compliance, blood pressure, cholesterol, and diabetes measurements.

If this study is successful, this simple strategy could be implemented by hospitals to improve medication compliance after discharge. This study will also provide more information about how patients' literacy skills affect their medication compliance.


Condition Intervention
Acute Coronary Syndrome (ACS)
Procedure: Graphic medication schedule (Pill card)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind
Official Title: Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Medication Compliance at one year

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

Estimated Enrollment: 250
Study Start Date: November 2006
  Eligibility

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

Inclusion Criteria:

- Present with acute chest pain or angina equivalent, lasting ≥ 10 minutes of suspected ischemic origin, within the previous 24 hours of presentation to the hospital.

PLUS

  • Patient must have documented objective evidence of myocardial ischemia based on a or b:

    1. EKG changes in ≥ 2 contiguous leads shown by:

      * Transient (< 30 min) ST-segment elevation of ≥ 1.0mm

      OR

      * Transient or persistent ST-segment depression of ≥ 0.5mm (flat or downsloping at the J-point and at 80ms after the J-point)

      OR

      * Persistent T-wave inversion of ≥ 2.0mm

    2. Abnormal elevation of cardiac enzymes

      * Elevation of creating kinase (CK) and creatine kinase-myocardial band (CK-MB)

      OR

      * Elevation of troponin

      Exclusion Criteria:

  • Previously enrolled in the study
  • Police custody
  • Corrected visual acuity worse than 20/60
  • Lack of cooperation
  • Severe hearing impairment
  • Too ill to participate
  • Unintelligible speech
  • Age younger than 18 years
  • Native language other than English
  • Psychotic illness
  • Caregiver administers all medications
  • Delirium/severe dementia
  • Does not fill prescriptions at Grady
  • No regular telephone/address
  • Not taking chronic medications prior to admission
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399880

Contacts
Contact: Sunil Kripalani, MD, MSc 404-778-1627 skripal@emory.edu
Contact: Rashanda Robertson, MPH 404-778-1654 rsrober@emory.edu

Locations
United States, Georgia
Grady Memorial Hospital Not yet recruiting
Atlanta, Georgia, United States, 30303
Contact: Sunil Kripalani, MD, MSc     404-778-1627     skripal@emory.edu    
Principal Investigator: Sunil Kripalani, MD, MSc            
Sponsors and Collaborators
Emory University
American Society of Health-System Pharmacists Research and Education Foundation
Investigators
Principal Investigator: Sunil Kripalani, MD, MSc Emory University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00399880     History of Changes
Other Study ID Numbers: 00000116
Study First Received: November 13, 2006
Last Updated: June 15, 2009
Health Authority: Uinited States: Institutional Review Board

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Clinical Trial
Behavioral/Social
Cardiovascular Disease
Risk Factors/Analysis

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013