Active — Not RecruitingNot Applicable

Self-management Intervention for Reducing Epilepsy Burden Among Ugandans With Epilepsy.

Uganda190 participantsStarted 2025-01-06

Plain-language summary

The goal of this clinical trial is to assess the efficacy of self management intervention for reducing epilepsy burden among Ugandans with epilepsy (SMART- U) vs. enhanced treatment as usual (eTAU) via an RCT in adults with epilepsy. The main question\[s\] it aims to answer are: * What is the efficacy of SMART - Uganda (SMART-U) versus enhanced treatment as usual (eTAU) among PWE? * How does short message service (SMS) delivered by mobile phone text validate self-reported seizure occurrence? Participants will be randomly (1:1 basis) assigned to receive either SMART-U (N=94) or eTAU (N=94) using block randomization. SMART-U will consist of 2 main components: a 12-week "intensive" group format stage and a 12-week remotely accessed telephone follow-up stage. Individuals randomized to eTAU will continue in their usual care supplemented by written materials on epilepsy in their preferred language and tailored to the reading level of most patients at the clinic. If there is a comparison group: The investigators will compare the mean change in seizure frequency and quality of life from baseline and 24 weeks of follow up.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participants will have a clinical diagnosis of epilepsy documented with at least two outpatients visits; this will ensure that the study participants have been taking ASMs but still getting breakthrough seizures.
. ≥ age 18, attending the neurology clinics,
. Be able to provide written informed consent by the study participant or immediate caregiver/legal guardian,
. Ability to participate in study procedures, this is due to time required to attend and participate in the scheduled sessions which may last between 45mins - 1 hour.
. and have had at least 1 seizure in the past 6 months.
. Owning a mobile phone either by the PWE or immediate caregiver

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean change in cumulative past 24-week seizure frequency (24 weeks prior to study baseline compared to the 24-week follow-up

Timeframe: 24 weeks

Mean change from baseline to 24 weeks in QOL. QOL will be assessed by the 31-item Quality of Life in Epilepsy (QOLIE-31) questionnaire.

Timeframe: 24 weeks

Trial details

NCT IDNCT06139198

SponsorMakerere University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-31

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