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

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ClinicalTrials.gov Identifier: NCT00399880
Recruitment Status : Completed
First Posted : November 15, 2006
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
American Society of Health-System Pharmacists Research and Education Foundation
Information provided by (Responsible Party):
Sunil Kripalani, Vanderbilt University Medical Center

November 13, 2006
November 15, 2006
June 1, 2017
September 25, 2017
September 25, 2017
November 2006
August 2008   (Final data collection date for primary outcome measure)
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.
Medication Compliance at one year
Complete list of historical versions of study NCT00399880 on ClinicalTrials.gov Archive Site
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.
Improved blood pressure, cholesterol, and diabetic control at one year
Not Provided
Not Provided
 
Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes
Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Acute Coronary Syndrome (ACS)
Behavioral: Health literacy intervention
Illustrated medication schedules, pill boxes, pharmacist counseling
  • Experimental: Health literacy intervention
    Illustrated medication schedules, pill boxes, pharmacist counseling
    Intervention: Behavioral: Health literacy intervention
  • No Intervention: Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
250
August 2008
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00399880
00000116
K23HL077597 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Sunil Kripalani, Vanderbilt University Medical Center
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
Vanderbilt University Medical Center
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP