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

NCT06139198 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Self-MAnagement intervention for Reducing The epilepsy burden among Ugandans

SMART-U sessions are operationalized in written curricula, including an intervention manual, participant manual, slides, and handouts typically delivered over a period of 10-12 weeks.

Sponsors & Collaborators

  • Case Western Reserve University

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • Mbarara University of Science and Technology

    collaborator OTHER

  • Makerere University

    lead OTHER

Principal Investigators

  • Mark Kaddumukasa, MD · Makerere University

  • Martha Sajatovic, MD · Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-06
Primary Completion
2027-07-31
Completion
2028-07-31

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06139198 on ClinicalTrials.gov