Clinical trial NCT06634901: Health Literacy Project
Official title: The Impact of Health Literacy Education on Knowledge, Treatment Adherence and Stigma Among Adolescents With Epilepsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Mbarara Regional Referral Hospital
name: Butabika National Referral Mental Hospital
First posted: 2024-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Epilepsy Knowledge, Attitudes, and Practices (KAP)
timeFrame: 20 minutes
Secondary outcomes:
measure: Kilifi Stigma Scale
timeFrame: 10 minutes
measure: Voils Medication Adherence Items
timeFrame: 3-minutes
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mayanja Memorial Hospital
city: Mbarara
country: Uganda
facility: Mbarara Regional Referral Hospital
Study officials:
affiliation: Duke University
name: Deborah Koltai, MD
role: PRINCIPAL_INVESTIGATOR
References:
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