Health TrialsbyHealthPanel

Health Literacy Project

ConditionEpilepsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Health Literacy Educational Session- Comparator

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Health Literacy Educational Session- Control Group TestingActive comparator 2 interventions
Group B: Health Literacy Educational Session- Experimental Group TestingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Epilepsy Knowledge, Attitudes, and Practices (KAP)

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).

Time frame
20 minutes

Secondary outcomes

1

Kilifi Stigma Scale

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)

Time frame
10 minutes
2

Voils Medication Adherence Items

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).

Time frame
3-minutes

Other outcomes

Sponsors and contacts

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Duke University

Lead sponsor

Mbarara Regional Referral Hospital

Collaborator

Butabika National Referral Mental Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: