Self-management program to reduce epilepsy burden in Ugandans.
Self-Management Intervention for Reducing Stroke Burden Among Ugandans With Epilepsy
NA · Makerere University · NCT06139198
This study is testing a new self-management program for adults with epilepsy in Uganda to see if it can help them feel better and have fewer seizures compared to standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Makerere University (other) |
| Locations | 1 site (Kampala) |
| Trial ID | NCT06139198 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a self-management intervention called SMART-U for adults with epilepsy in Uganda, comparing it to enhanced treatment as usual (eTAU). Participants will be randomly assigned to either the SMART-U program, which includes group sessions and follow-up support via phone, or to eTAU, which consists of standard care supplemented with educational materials. The study aims to improve quality of life, reduce seizure frequency, and enhance overall health outcomes for individuals living with epilepsy. The intervention will also assess the validity of self-reported seizure occurrences through mobile phone text messages.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of epilepsy who have experienced at least one seizure in the past six months.
Not a fit: Patients with dementia, those who are pregnant, or individuals unable to participate in study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life and seizure management for patients with epilepsy in Uganda.
How similar studies have performed: Other studies have shown promise in using self-management interventions for epilepsy, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. ≥ age 18, attending the neurology clinics, 3. Be able to provide written informed consent by the study participant or immediate caregiver/legal guardian, 4. 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. 5. and have had at least 1 seizure in the past 6 months. 6. Owning a mobile phone either by the PWE or immediate caregiver Exclusion Criteria: 1. Participants with dementia 2. 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. 3. Or those who are unable to participate in study procedures.
Where this trial is running
Kampala
- Mulago National Referral and Teaching Hospital — Kampala, Uganda (RECRUITING)
Study contacts
- Principal investigator: Mark Kaddumukasa, MD — Makerere University
- Study coordinator: Doreen Birungi, BA
- Email: bdoreen112@gmail.com
- Phone: +256772474096
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epilepsy, seizure frequency, self management, SMS, quality of life