Health Literacy Project

May 8, 2026 updated by: Duke University

The Impact of Health Literacy Education on Knowledge, Treatment Adherence and Stigma Among Adolescents With Epilepsy

Evaluating changes in knowledge, attitude, and practices (KAP) related to epilepsy and its treatment as a result of an educational intervention among adolescents with epilepsy to determine if improved KAP about epilepsy results in improved medication adherence and less perceived stigma.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This proof-of-concept study aims to evaluate the impact of a targeted health literacy intervention on knowledge and attitudes about epilepsy and its treatment, and reported medication adherence and stigma among adolescents with epilepsy in Uganda.

Research Questions:

  1. What is the impact of a culturally relevant information session on the knowledge of epilepsy and its treatment among adolescents with epilepsy in Uganda?
  2. What is the impact of such an educational session on reported medication adherence and reported stigma among this group?

The investigators hypothesize that a culturally relevant educational intervention will significantly improve knowledge about epilepsy and its treatment, increase medication adherence, and reduce stigma among adolescents with epilepsy in Uganda. This hypothesis is based on the premise that tailored health literacy interventions can address specific misconceptions and barriers to care, thereby improving health outcomes for PWE (persons with epilepsy) in contexts burdened by significant treatment gaps and cultural stigmatization.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Uganda
      • Mbarara, Uganda
        • Mbarara Regional Referral Hospital
      • Mbarara, Uganda
        • Mayanja Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adolescents with a diagnosis of epilepsy attending a clinic at one of the study sites.
  • Ages 12-18 years
  • Ability and willingness to provide informed assent and guardian consent to participate in the study.
  • English, Runyankole or Luganda language proficiency.

Exclusion Criteria:

  • Unable or unwilling to provide informed consent or assent to participate in the study.
  • Developmental/cognitive challenges that hinder participation in the intervention or completion of surveys.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Health Literacy Educational Session- Control Group Testing
Participants will receive pre- and post-testing at the same interval as the experimental arm. Rather than receiving the educational session intervention, participants will have lunch during the interval. The comparator group will receive the intervention after all primary and secondary outcome measures have been completed.
Other: Health Literacy Educational Session- Comparator
During the pre-to-post-test interval for the Knowledge, Attitudes, and Practices (KAP) measure, participants in this arm will take a break and have lunch.
Behavioral: Health Literacy Educational Session
The Intervention is a 90 minute small group (n=6-10) session with an expert epilepsy provider reviewing fundamental information about epilepsy being a treatable neurologic condition, with topics including epidemiology, causation facts and myths, treatment and the importance of consistent medication, stigma, barriers to care and well-being. These topics will be covered in the first 45 minutes, leaving the second 45 minutes for Q&A with the expert. This session provides the basic health information relevant to people with epilepsy, communication of which is often sacrificed in overcrowded clinics found in low resource settings.
Experimental: Health Literacy Educational Session- Experimental Group Testing
Participants are divided into groups of 6-10 adolescents each to receive the educational session intervention, with those aged 12-15 in different groups from those aged 16-18 due to potential differences in question focus.
Behavioral: Health Literacy Educational Session
The Intervention is a 90 minute small group (n=6-10) session with an expert epilepsy provider reviewing fundamental information about epilepsy being a treatable neurologic condition, with topics including epidemiology, causation facts and myths, treatment and the importance of consistent medication, stigma, barriers to care and well-being. These topics will be covered in the first 45 minutes, leaving the second 45 minutes for Q&A with the expert. This session provides the basic health information relevant to people with epilepsy, communication of which is often sacrificed in overcrowded clinics found in low resource settings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epilepsy Knowledge, Attitudes, and Practices (KAP)
Time Frame: 20 minutes
The primary outcome measure is a 31-item Knowledge, Attitudes, and Practices (KAP) about epilepsy survey. The questionnaire was adapted from Krishnaiah and colleagues (2016), and measures basic knowledge about and attitudes toward epilepsy. Epilepsy Knowledge & Attitudes (KAP) has a reporting scale: 0-31 (higher better).
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kilifi Stigma Scale
Time Frame: 10 minutes
This 15-item survey was developed and validated in Kilifi, Kenya to measure stigma, and has been used extensively in epilepsy survey research in East Africa. The reporting scale for the Kilifi Stigma Scale: 0-30 (higher worse)
10 minutes
Voils Medication Adherence Items
Time Frame: 3-minutes
Three items from Voils Medication Adherence (2012) measure will be used to estimate reported medication adherence. The reporting scale for Voil's Medication Adherence: 3-15 (higher worse).
3-minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Mbarara Regional Referral Hospital
Butabika National Referral Mental Hospital

Investigators

  • Principal Investigator: Deborah Koltai, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

October 8, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00116250

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy

Clinical Trials on Health Literacy Educational Session- Comparator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe