Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-12-01
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Health Literacy Educational Session- Control Group Testing
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.
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.
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 information relevant to people with epilepsy, communication of which is often sacrificed in overcrowded clinics found in low resource settings.
Health Literacy Educational Session- Experimental Group Testing
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.
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 information relevant to people with epilepsy, communication of which is often sacrificed in overcrowded clinics found in low resource settings.
Interventions
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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.
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 information relevant to people with epilepsy, communication of which is often sacrificed in overcrowded clinics found in low resource settings.
Eligibility Criteria
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Inclusion Criteria
* 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
* Developmental/cognitive challenges that hinder participation in the intervention or completion of surveys.
12 Years
18 Years
ALL
No
Sponsors
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Mbarara Regional Referral Hospital
UNKNOWN
Butabika National Referral Mental Hospital
UNKNOWN
Duke University
OTHER
Responsible Party
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Principal Investigators
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Deborah Koltai, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Mayanja Memorial Hospital
Mbarara, , Uganda
Mbarara Regional Referral Hospital
Mbarara, , Uganda
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Kaddumukasa MN, Kaddumukasa M, Kajumba M, Smith PJ, Bobholz S, Kakooza-Mwesige A, Sinha DD, Almojuela A, Chakraborty P, Nakasujja N, Nakku J, Gualtieri A, Onuoha E, Kolls BJ, Muhumuza C, Smith CE, Sanchez N, Fuller AT, Haglund MM, Koltai DC. Barriers to biomedical care for people with epilepsy in Uganda: A cross-sectional study. Epilepsy Behav. 2021 Jan;114(Pt B):107349. doi: 10.1016/j.yebeh.2020.107349. Epub 2020 Sep 20.
Beghi E. The Epidemiology of Epilepsy. Neuroepidemiology. 2020;54(2):185-191. doi: 10.1159/000503831. Epub 2019 Dec 18.
Scott AJ, Sharpe L, Hunt C, Gandy M. Anxiety and depressive disorders in people with epilepsy: A meta-analysis. Epilepsia. 2017 Jun;58(6):973-982. doi: 10.1111/epi.13769. Epub 2017 May 3.
Adewuya AO, Ola BA. Prevalence of and risk factors for anxiety and depressive disorders in Nigerian adolescents with epilepsy. Epilepsy Behav. 2005 May;6(3):342-7. doi: 10.1016/j.yebeh.2004.12.011.
Mbuba CK, Newton CR. Packages of care for epilepsy in low- and middle-income countries. PLoS Med. 2009 Oct;6(10):e1000162. doi: 10.1371/journal.pmed.1000162. Epub 2009 Oct 13.
Nicholas A. Unlocking the hidden burden of epilepsy in Africa: Understanding the challenges and harnessing opportunities for improved care. Health Sci Rep. 2023 Apr 17;6(4):e1220. doi: 10.1002/hsr2.1220. eCollection 2023 Apr.
Krishnaiah B, Alwar SP, Ranganathan LN. Knowledge, attitude, and practice of people toward epilepsy in a South Indian village. J Neurosci Rural Pract. 2016 Jul-Sep;7(3):374-80. doi: 10.4103/0976-3147.181490.
Mbuba CK, Abubakar A, Odermatt P, Newton CR, Carter JA. Development and validation of the Kilifi Stigma Scale for Epilepsy in Kenya. Epilepsy Behav. 2012 May;24(1):81-5. doi: 10.1016/j.yebeh.2012.02.019. Epub 2012 Apr 4.
Voils CI, Maciejewski ML, Hoyle RH, Reeve BB, Gallagher P, Bryson CL, Yancy WS Jr. Initial validation of a self-report measure of the extent of and reasons for medication nonadherence. Med Care. 2012 Dec;50(12):1013-9. doi: 10.1097/MLR.0b013e318269e121.
Cicero CE, Giuliano L, Todaro V, Colli C, Padilla S, Vilte E, Crespo Gomez EB, Camargo Villarreal WM, Bartoloni A, Zappia M, Nicoletti A. Comic book-based educational program on epilepsy for high-school students: Results from a pilot study in the Gran Chaco region, Bolivia. Epilepsy Behav. 2020 Jun;107:107076. doi: 10.1016/j.yebeh.2020.107076. Epub 2020 Apr 18.
Other Identifiers
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PRO00116250
Identifier Type: -
Identifier Source: org_study_id
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