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

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.
ClinicalTrials.gov Identifier: NCT00399880
Recruitment Status : Completed
First Posted : November 15, 2006
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Acute Coronary Syndrome (ACS) Behavioral: Health literacy intervention

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes
Study Start Date : November 2006
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Literacy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Health literacy intervention
Illustrated medication schedules, pill boxes, pharmacist counseling
Behavioral: Health literacy intervention
Illustrated medication schedules, pill boxes, pharmacist counseling
No Intervention: Usual care

Outcome Measures

Primary Outcome Measures :
  1. Adherence to Refills and Medications Scale (ARMS) [ Time Frame: Approximately 2 weeks after hospital discharge ]
    Validated self-report measure of medication adherence. Possible range 12-48, with lower values indicating better adherence.

Secondary Outcome Measures :
  1. Self-Efficacy for Appropriate Medication Use Scale (SEAMS) [ Time Frame: Approximately 2 weeks after hospital discharge ]
    Validated measure of confidence in taking medications correctly. Possible range 13-39, with higher values indicating greater confidence.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


  • 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


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


      * 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)


      * 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399880

United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Vanderbilt University Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
American Society of Health-System Pharmacists Research and Education Foundation
Principal Investigator: Sunil Kripalani, MD, MSc Vanderbilt University Medical Center
More Information

Responsible Party: Sunil Kripalani, Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00399880     History of Changes
Other Study ID Numbers: 00000116
K23HL077597 ( U.S. NIH Grant/Contract )
First Posted: November 15, 2006    Key Record Dates
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017
Last Verified: July 2017

Keywords provided by Sunil Kripalani, Vanderbilt University Medical Center:
Clinical Trial
Cardiovascular Disease
Risk Factors/Analysis

Additional relevant MeSH terms:
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases