NCT06139198Active, not recruiting
Self-management Intervention for Reducing Epilepsy Burden Among Ugandans With Epilepsy.
Self-Management Intervention for Reducing Stroke Burden Among Ugandans With Epilepsy
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 190 (actual)
- First submitted
- 14 Nov 2023
- Start date
- 6 Jan 2025
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Makerere University
- NCT number
- NCT06139198
What you commit to
- Study type: Interventional
- Participants enrolled: 190
- From 6 Jan 2025 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participants with dementia
Other
- Participants who are pregnant (given the likely need of different and more intensive treatments among pregnant PWE that may affect their ability to participate in the SMART-U sessions regularly.
- Or those who are unable to participate in study procedures.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mulago National Referral and Teaching Hospital Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.