EpilepsyNCT06634901
Health Literacy Project
A study testing Health Literacy Educational Session- Comparator and Health Literacy Educational Session in people with Epilepsy, run by Duke University at 2 sites in Uganda.
Trial 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 more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Health Literacy Educational Session- Comparator and Health Literacy Educational Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUganda
- Study dates
- 1 Nov 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda2 sites
Mayanja Memorial Hospital
Mbarara
Mbarara Regional Referral Hospital
Mbarara
About this study
Official title: The Impact of Health Literacy Education on Knowledge, Treatment Adherence and Stigma Among Adolescents With Epilepsy
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:
- What is the impact of a culturally relevant information session on the knowledge of epilepsy and its treatment among adolescents with epilepsy in Uganda?
- 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
- Epilepsy
- Being tested
- Health Literacy Educational Session- Comparator, Health Literacy Educational Session
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Literacy Educational Session- ComparatorOther
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 SessionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Health Literacy Educational Session- Control Group Testing | Active comparator | 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. Receives: Other: Health Literacy Educational Session- Comparator; Behavioral: Health Literacy Educational Session |
| Health Literacy Educational Session- Experimental Group Testing | Experimental | 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. Receives: Behavioral: Health Literacy Educational Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 20 minutes
Secondary outcomes (2)
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)
Measured: 10 minutes
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).
Measured: 3-minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Nov 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Mbarara Regional Referral Hospital, Butabika National Referral Mental Hospital
- Responsible party
- Sponsor
- Investigators
- Deborah Koltai, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634901
- Sponsor's protocol ID
- PRO00116250
- Status last verified
- Sep 2026
- First submitted
- 8 Oct 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 38475724Meyer 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 20431789Owolabi 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 32219865Kirabira 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 29567525Sanchez 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 32758404Kaddumukasa 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 29906697Ngugi 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 21893672Ba-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 25231525Kaddumukasa 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 32962922Beghi E. The Epidemiology of Epilepsy. Neuroepidemiology. 2020;54(2):185-191. doi: 10.1159/000503831. Epub 2019 Dec 18.
PubMed 31852003Scott 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 28470748Adewuya 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 15820341Mbuba 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 19823570Nicholas 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 37081998Krishnaiah 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Health Literacy Education on Knowledge, Treatment Adherence and Stigma Among Adolescents With Epilepsy
- ClinicalTrials.gov ID
- NCT06634901
- Acronym / sponsor ID
- PRO00116250
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Mbarara Regional Referral Hospital, Butabika National Referral Mental Hospital
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the impact of a culturally relevant information session on the knowledge of epilepsy and its treatment among adolescents with epilepsy in Uganda?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Literacy Educational Session- Control Group Testing | Active comparator | Other: Health Literacy Educational Session- Comparator, Behavioral: Health Literacy Educational SessionParticipants 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- Experimental Group Testing | Experimental | Behavioral: Health Literacy Educational SessionParticipants 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Literacy Educational Session- ComparatorDuring 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. | Other | Health Literacy Educational Session- Control Group Testing |
| Health Literacy Educational SessionThe 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. | Behavioural | Health Literacy Educational Session- Control Group Testing, Health Literacy Educational Session- Experimental Group Testing |
Primary outcome
Epilepsy Knowledge, Attitudes, and Practices (KAP)
Time frame: 20 minutes
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).
2 secondary outcomes
Kilifi Stigma Scale
Time frame: 10 minutes
Voils Medication Adherence Items
Time frame: 3-minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 38475724Biset 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.
- Background: PubMed 20431789Meyer 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.
- Background: PubMed 32219865Owolabi 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.
- Background: PubMed 29567525Kirabira 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.
- Background: PubMed 32758404Sanchez 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.
- Background: PubMed 29906697Kaddumukasa 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.
- Background: PubMed 21893672Ngugi 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.
- Background: PubMed 25231525Ba-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.
- Background: PubMed 32962922Kaddumukasa 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.
- Background: PubMed 31852003Beghi E. The Epidemiology of Epilepsy. Neuroepidemiology. 2020;54(2):185-191. doi: 10.1159/000503831. Epub 2019 Dec 18.
- Background: PubMed 28470748Scott 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.
- Background: PubMed 15820341Adewuya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deborah Koltai, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Literacy Educational Session- Comparator and Health Literacy Educational Session in people with Epilepsy, run by Duke University at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah Koltai, MD (919-812-0808, attix001@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epilepsy Knowledge, Attitudes, and Practices (KAP) (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06634901, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.