Health Literacy Project

Duke University

Status: Begins enrollment this month

Conditions: Epilepsy

Treatments: Behavioral: Health Literacy Educational Session; Other: Health Literacy Educational Session- Comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT06634901

PRO00116250

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Health Literacy Educational Session- Control Group Testing

Active Comparator group

Description:

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.

Treatment:

Other: Health Literacy Educational Session- Comparator

Behavioral: Health Literacy Educational Session

Health Literacy Educational Session- Experimental Group Testing

Experimental group

Description:

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.

Treatment:

Behavioral: Health Literacy Educational Session