Health Literacy Project

Official title

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

Overview

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.

Interventions

• Other Health Literacy Educational Session- Comparator
  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.
• Behavioral Health Literacy Educational Session
  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 informati

Primary outcome measures

• Epilepsy Knowledge, Attitudes, and Practices (KAP) [Time frame: 20 minutes]

Secondary outcome measures (2)

• Kilifi Stigma Scale [Time frame: 10 minutes]
• Voils Medication Adherence Items [Time frame: 3-minutes]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Supportive care

Study locations

Uganda · 2 centers

• Mayanja Memorial Hospital — Mbarara
• Mbarara Regional Referral Hospital — Mbarara

Publications

• Biset G, Abebaw N, Gebeyehu NA, Estifanos N, Birrie E, Tegegne KD. Prevalence, incidence, and trends of epilepsy among children and adolescents in Africa: a systematic review and meta-analysis. BMC Public Health. 2024 Mar 12;24(1):771. doi: 10.1186/s12889-024-18236-z. PMID 38475724
• Meyer AC, Dua T, Ma J, Saxena S, Birbeck G. Global disparities in the epilepsy treatment gap: a systematic review. Bull World Health Organ. 2010 Apr;88(4):260-6. doi: 10.2471/BLT.09.064147. Epub 2009 Sep 25. PMID 20431789
• Owolabi LF, Owolabi SD, Adamu B, Jibo AM, Alhaji ID. Epilepsy treatment gap in Sub-Saharan Africa: Meta-analysis of community-based studies. Acta Neurol Scand. 2020 Jul;142(1):3-13. doi: 10.1111/ane.13246. Epub 2020 Apr 14. PMID 32219865
• Kirabira J, Nakawuki M, Fallen R, Zari Rukundo G. Perceived stigma and associated factors among children and adolescents with epilepsy in south western Uganda: A cross sectional study. Seizure. 2018 Apr;57:50-55. doi: 10.1016/j.seizure.2018.03.008. Epub 2018 Mar 8. PMID 29567525
• Sanchez N, Kajumba M, Kalyegira J, Sinha DD, Bobholz S, Gualtieri A, Chakraborty P, Onuoha E, Fuller AT, Teuwen DE, Haglund MM, Koltai DC. Stakeholder views of the practical and cultural barriers to epilepsy care in Uganda. Epilepsy Behav. 2021 Jan;114(Pt B):107314. doi: 10.1016/j.yebeh.2020.107314. Epub 2020 Aug 3. PMID 32758404
• Kaddumukasa M, Kaddumukasa MN, Buwembo W, Munabi IG, Blixen C, Lhatoo S, Sewankambo N, Katabira E, Sajatovic M. Epilepsy misconceptions and stigma reduction interventions in sub-Saharan Africa, a systematic review. Epilepsy Behav. 2018 Aug;85:21-27. doi: 10.1016/j.yebeh.2018.04.014. Epub 2018 Jun 13. PMID 29906697
• Ngugi AK, Kariuki SM, Bottomley C, Kleinschmidt I, Sander JW, Newton CR. Incidence of epilepsy: a systematic review and meta-analysis. Neurology. 2011 Sep 6;77(10):1005-12. doi: 10.1212/WNL.0b013e31822cfc90. PMID 21893672
• Ba-Diop A, Marin B, Druet-Cabanac M, Ngoungou EB, Newton CR, Preux PM. Epidemiology, causes, and treatment of epilepsy in sub-Saharan Africa. Lancet Neurol. 2014 Oct;13(10):1029-44. doi: 10.1016/S1474-4422(14)70114-0. PMID 25231525

Identifiers

NCT: NCT06634901 · PRO00116250

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗