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Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes

Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00399880
Acronym
IMAGE-ACS
Enrollment
130
Registered
2006-11-15
Start date
2006-11-30
Completion date
2008-08-31
Last updated
2017-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome (ACS)

Keywords

Clinical Trial, Behavioral/Social, Cardiovascular Disease, Risk Factors/Analysis

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.

Interventions

Illustrated medication schedules, pill boxes, pharmacist counseling

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
American Society of Health-System Pharmacists Research and Education Foundation
CollaboratorOTHER
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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. 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

Design outcomes

Primary

MeasureTime frameDescription
Adherence to Refills and Medications Scale (ARMS)Approximately 2 weeks after hospital dischargeValidated self-report measure of medication adherence. Possible range 12-48, with lower values indicating better adherence.

Secondary

MeasureTime frameDescription
Self-Efficacy for Appropriate Medication Use Scale (SEAMS)Approximately 2 weeks after hospital dischargeValidated measure of confidence in taking medications correctly. Possible range 13-39, with higher values indicating greater confidence.

Countries

United States

Participant flow

Participants by arm

ArmCount
Health Literacy Intervention
Illustrated medication schedules, pill boxes, pharmacist counseling Health literacy intervention: Illustrated medication schedules, pill boxes, pharmacist counseling
65
Usual Care
Usual care arm
65
Total130

Baseline characteristics

CharacteristicHealth Literacy InterventionTotalUsual Care
Age, Continuous52.6 years
STANDARD_DEVIATION 9.2
52.4 years
STANDARD_DEVIATION 9.9
52.2 years
STANDARD_DEVIATION 10.7
Education11.6 years
STANDARD_DEVIATION 3
11.6 years
STANDARD_DEVIATION 2.9
11.5 years
STANDARD_DEVIATION 2.9
Employment status
Full-time
5 Participants9 Participants4 Participants
Employment status
Missing
2 Participants3 Participants1 Participants
Employment status
Other (disabled, retired)
24 Participants60 Participants36 Participants
Employment status
Part-time
3 Participants7 Participants4 Participants
Employment status
Unemployed
31 Participants51 Participants20 Participants
Income
<$10,000
40 Participants84 Participants44 Participants
Income
$10,000-$20,000
18 Participants30 Participants12 Participants
Income
>$20,000
5 Participants10 Participants5 Participants
Income
Missing
2 Participants6 Participants4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
62 Participants125 Participants63 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Race (NIH/OMB)
White
2 Participants4 Participants2 Participants
Rapid Estimate of Adult Literacy in Medicine (REALM)41.1 units on a scale
STANDARD_DEVIATION 21.7
40.1 units on a scale
STANDARD_DEVIATION 22.1
39.1 units on a scale
STANDARD_DEVIATION 22.7
Sex: Female, Male
Female
27 Participants56 Participants29 Participants
Sex: Female, Male
Male
38 Participants74 Participants36 Participants
Smoking status
Current
33 Participants61 Participants28 Participants
Smoking status
Former
14 Participants19 Participants5 Participants
Smoking status
Missing
0 Participants3 Participants3 Participants
Smoking status
Never
18 Participants47 Participants29 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 650 / 65
other
Total, other adverse events
0 / 650 / 65
serious
Total, serious adverse events
0 / 650 / 65

Outcome results

Primary

Adherence to Refills and Medications Scale (ARMS)

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

Population: Participants who were able to be contacted and provided outcome data.

ArmMeasureValue (MEAN)Dispersion
Health Literacy InterventionAdherence to Refills and Medications Scale (ARMS)12.03 units on a scaleStandard Deviation 2.59
Usual CareAdherence to Refills and Medications Scale (ARMS)12.18 units on a scaleStandard Deviation 3.81
Secondary

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.

Time frame: Approximately 2 weeks after hospital discharge

Population: Participants who were able to be contacted and provided outcome data.

ArmMeasureValue (MEAN)Dispersion
Health Literacy InterventionSelf-Efficacy for Appropriate Medication Use Scale (SEAMS)32.8 units on a scaleStandard Deviation 4.8
Usual CareSelf-Efficacy for Appropriate Medication Use Scale (SEAMS)31.5 units on a scaleStandard Deviation 6.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026