Self-Management Intervention for Reducing Stroke Burden Among Ugandans With Epilepsy

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Uganda
Mulago National Referral and Teaching Hospital
RECRUITING
Kampala
Contact Information
Primary
Doreen Birungi, BA
bdoreen112@gmail.com
+256772474096
Time Frame
Start Date: 2025-01-06
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 188
Treatments
Experimental: SMART-U intervention arm
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.
No_intervention: Enhanced Treatment as usual
The participants will have usual care supplemented by written materials on epilepsy in their preferred language and tailored to the reading level of most patients at the clinic.
Related Therapeutic Areas
Sponsors
Collaborators: Mbarara University of Science and Technology, Children's Hospital Medical Center, Cincinnati, Case Western Reserve University
Leads: Makerere University

This content was sourced from clinicaltrials.gov