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NCT Number: NCT06634901

Health Literacy Project

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayanja Memorial Hospital, Mbarara, Uganda

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About this study

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:

  • What is the impact of a culturally relevant information session on the knowledge of epilepsy and its treatment among adolescents with epilepsy in Uganda?
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Health Literacy Educational Session- Comparator

Other

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.

Health Literacy Educational Session

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

  2. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Deborah Koltai, MD

CONTACT

[email protected]

919-812-0808

Paula Njeru, MsCGH

CONTACT

[email protected]

316-365-3238

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Butabika National Referral Mental Hospital
  • Mbarara Regional Referral Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Oct 10, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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