- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07389317
Assessing Illustrated Medication Labels
Assessing the Impact of Illustrated Medication Labels on Medication Understanding Among Migrant and Seasonal Farmworkers in South Georgia
The goal of this clinical trial is to evaluate the impact of graphic-based medication labels on medication understanding and to assess the health literacy of our farmworker population. The main questions it aims to answer are:
Primary Objective: Assess the impact of illustrated medication labels on medication understanding among migrant and seasonal farmworkers Secondary Objective: Evaluate the health literacy of the farmworker population in South Georgia
Participants will be given either medication labels with pictures or standard medication labels
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
-
-
Kentucky
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Lexington, Kentucky, United States, 40506
- University of Kentucky
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 and older
- Receiving medication education at Emory Farm Worker Project (EFP) clinics
Exclusion Criteria:
- Individuals unable to provide informed consent or participate in the study
- Those not requiring medication during their visit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard medication label
|
Standard Education Procedure: Based on best practices, including simple, standardized instructions in the participants' native language and the "teach-back" method.
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Experimental: Illustrated medication label
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Illustrated medication labels: Labels will include visuals for medication name, time of administration, food interactions, indications, and potential side effects
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication Understanding Questionnaire (MUQ)
Time Frame: Post intervention (10 minutes)
|
MUQ will assess participants' understanding of their medications after education.
Scores range from 0-3 to test medication purpose, dose, and frequency
|
Post intervention (10 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brief Health Literacy Screen (BHLS)
Time Frame: Post intervention (10 minutes)
|
The BHLS consists of 4 questions with each item being worth 1-5 points.
Total score range from 4-20 with higher score equating to greater health literacy
|
Post intervention (10 minutes)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jodie Guest, PhD, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 105049
- U54OH007547 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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