Clinical Trial

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

Study acronym: SMART
Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-11-14; most recent amendment 2026-05-06.
Status change: Recruiting → Active, Not Recruiting 2026-05-06
Status change: Not Yet Recruiting → Recruiting 2025-05-08
Trial Details
NCT Number NCT06139198
Lead Sponsor Makerere University
Collaborators: Case Western Reserve University, Children's Hospital Medical Center, Cincinnati, Mbarara University of Science and Technology
Conditions Epilepsy
Enrollment 190 participants
Start Date 2025-01-06
Primary Completion 2027-07-31 (estimated)
Study Completion 2028-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-11