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NCT06139198Not yet recruiting

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

Self-Management Intervention for Reducing Stroke Burden Among Ugandans With Epilepsy
Makerere UniversityClinicalTrials.govbehavioral
Study focus
Disease/Condition
Epilepsy
Drug/Device/Intervention
Self-MAnagement intervention for Reducing The epilepsy burden among Ugandans
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
Makerere University
Timeline & enrollment
Phase
N/A
Start date
Jul 01, 2024
End date
Jul 31, 2028
Enrollment
188 participants
Primary outcome

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

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: We will compare the mean change in seizure frequency and
 quality of life from baseline and 24 weeks of follow up.

ICD-10 classifications
EpilepsyEpilepsy, unspecifiedOther epilepsyStatus epilepticusOther status epilepticus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06139198
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06139198 through Pure Global AI's free database. This phase not specified trial is sponsored by Makerere University and is currently Not yet recruiting. The study focuses on Epilepsy. Target enrollment is 188 participants.

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