Health Literacy Project

Not Applicable

Not yet recruiting

• Conditions: Epilepsy
• Interventions: Other: Health Literacy Educational Session- Comparator; Behavioral: Health Literacy Educational Session

• Registration Number: NCT06634901
• Lead Sponsor: Duke University

Brief Summary

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.

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 Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-08
• Study First Posted: 2024-10-10
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16
• Study Start: 2025-06-02
• Primary Completion: 2025-09-04
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Health Literacy Educational Session- Control Group Testing	Health Literacy Educational Session- Comparator	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.
Health Literacy Educational Session- Control Group Testing	Health Literacy Educational Session	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.
Health Literacy Educational Session- Experimental Group Testing	Health Literacy Educational Session	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.

Primary Outcome Measures

Name	Time	Method
Epilepsy Knowledge, Attitudes, and Practices (KAP)	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).

Secondary Outcome Measures

Name	Time	Method
Voils Medication Adherence Items	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).
Kilifi Stigma Scale	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)

Trial Locations

Locations (2)

Mbarara Regional Referral Hospital; 🇺🇬 Mbarara, Uganda

Mayanja Memorial Hospital; 🇺🇬 Mbarara, Uganda