Status:
RECRUITING
Self-management Intervention for Reducing Epilepsy Burden Among Ugandans With Epilepsy.
Lead Sponsor:
Makerere University
Collaborating Sponsors:
Case Western Reserve University
Children's Hospital Medical Center, Cincinnati
Conditions:
Epilepsy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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) vi...
Detailed Description
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. SMART-U will be assessed for acceptability and fidelity, ...
Eligibility Criteria
Inclusion
- 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
- Participants with dementia
- 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.
Key Trial Info
Start Date :
January 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT06139198
Start Date
January 6 2025
End Date
July 31 2028
Last Update
May 13 2025
Active Locations (1)
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1
Mulago National Referral and Teaching Hospital
Kampala, Uganda