ClinicalTrials.gg
Not yet recruitingNCT06634901Updated Sep 9, 2026

Health Literacy Project

An interventional study of Health Literacy Educational Session- Comparator and Health Literacy Educational Session in Epilepsy, sponsored by Duke University. Not yet recruiting at 2 sites in Uganda. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Duke University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Epilepsy

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03

In context

Epilepsy

1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 1,239 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Unable or unwilling to provide or assent to participate in the study.
  • Developmental/cognitive challenges that hinder participation in the intervention or completion of surveys.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    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.

    Other: Health Literacy Educational Session- Comparator · Behavioral: Health Literacy Educational Session

  • Experimental
    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.

    Behavioral: Health Literacy Educational Session

Interventions

  • OtherHealth 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.

  • BehavioralHealth 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.

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What researchers measure

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

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Study locations

2 sites
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References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 25231525 ↗
  • 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. PubMed 32962922 ↗
  • Beghi E. The Epidemiology of Epilepsy. Neuroepidemiology. 2020;54(2):185-191. doi: 10.1159/000503831. Epub 2019 Dec 18. PubMed 31852003 ↗
  • 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. PubMed 28470748 ↗
  • 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. PubMed 15820341 ↗
  • 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. PubMed 19823570 ↗
  • 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. PubMed 37081998 ↗
  • 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. PubMed 27365954 ↗
  • 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. PubMed 22481043 ↗
  • 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. PubMed 22922431 ↗
  • 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. PubMed 32315969 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06634901
Lead sponsor
Duke University
Collaborators
Mbarara Regional Referral Hospital, Butabika National Referral Mental Hospital
Responsible party
Sponsor
First posted
Oct 10, 2024
Start date
Nov 1, 2026 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

Deborah Koltai, MD
Contact
attix001@duke.edu
919-812-0808
Paula Njeru, MsCGH
Contact
paula.njeru@duke.edu
316-365-3238
Deborah Koltai, MD
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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