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

Primary Purpose

Acute Coronary Syndrome (ACS)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health literacy intervention
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome (ACS) focused on measuring Clinical Trial, Behavioral/Social, Cardiovascular Disease, Risk Factors/Analysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grady Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Health literacy intervention

Usual care

Arm Description

Illustrated medication schedules, pill boxes, pharmacist counseling

Outcomes

Primary Outcome Measures

Adherence to Refills and Medications Scale (ARMS)
Validated self-report measure of medication adherence. Possible range 12-48, with lower values indicating better adherence.

Secondary Outcome Measures

Self-Efficacy for Appropriate Medication Use Scale (SEAMS)
Validated measure of confidence in taking medications correctly. Possible range 13-39, with higher values indicating greater confidence.

Full Information

First Posted
November 13, 2006
Last Updated
July 28, 2017
Sponsor
Vanderbilt University Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), American Society of Health-System Pharmacists Research and Education Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00399880
Brief Title
Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes
Acronym
IMAGE-ACS
Official Title
Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), American Society of Health-System Pharmacists Research and Education Foundation

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome (ACS)
Keywords
Clinical Trial, Behavioral/Social, Cardiovascular Disease, Risk Factors/Analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health literacy intervention
Arm Type
Experimental
Arm Description
Illustrated medication schedules, pill boxes, pharmacist counseling
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Health literacy intervention
Intervention Description
Illustrated medication schedules, pill boxes, pharmacist counseling
Primary Outcome Measure Information:
Title
Adherence to Refills and Medications Scale (ARMS)
Description
Validated self-report measure of medication adherence. Possible range 12-48, with lower values indicating better adherence.
Time Frame
Approximately 2 weeks after hospital discharge
Secondary Outcome Measure Information:
Title
Self-Efficacy for Appropriate Medication Use Scale (SEAMS)
Description
Validated measure of confidence in taking medications correctly. Possible range 13-39, with higher values indicating greater confidence.
Time Frame
Approximately 2 weeks after hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Kripalani, MD, MSc
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States

12. IPD Sharing Statement

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Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes

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