Document Type
Article
Publication Date
12-2-2023
Abstract
Background:Epilepsy is a common chronic brain disorder globally affecting people of all ages, with the majority living in developing countries. The introduction of epilepsy self-management approaches to help people with epilepsy is urgently needed to influence epilepsy-related outcomes. This 2-site randomised controlled trial building on promising preliminary data is intended to explore this further. Methods: A total of 188 adult people with epilepsy (PWE) attending the neurology clinics at Mulago and Mbarara hospitals and consent to participate in the study will be recruited. They will be randomised into intervention versus enhanced treatment control (eTAU) study groups. The intervention group will receive 12-week “intensive” educational sessions and a 12-week remotely accessed telephone follow-up stage. The controls 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. SMART-U consists 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, fidelity, and efficacy compared to eTAU. The primary study outcome is the mean change in cumulative past 24-week seizure frequency (24 weeks prior to the study baseline compared to the 24-week follow-up). Seizure frequency will be via self-report with corroboration by family/support system informants whenever possible. Participants will self-report the seizure frequency (numeric count) that they experienced between baseline and 13 weeks and again between 13 and 24 weeks, and the mean change from baseline to 24 weeks in QOL. Discussion: The curriculum-guided Self-Management intervention for Reducing The epilepsy burden among Ugandans (SMART-U) program is anticipated to reduce the epilepsy burden seizure frequency and improve other health outcomes, including depression, functional status and health resource use.
Keywords
epilepsy, intervention, self-management, targeted management
Language
English
Publication Title
Neuropsychiatric Disease and Treatment
Grant
R01NS129041
Rights
© 2024 The Author(s). This is an open access article under the CC BY-NC license (https://creativecommons.org/licenses/by-nc/3.0/), which permits non-commercial reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
Recommended Citation
Mbalinda SN, Kaddumukasa M, Najjuma J, Birungi D, Kaddumukasa M, Levin J, Still C, Burant C, Modi A, Katabira ET, Sajatovic M. Self-management Intervention for Reducing Epilepsy Burden Among Adult Ugandans With Epilepsy (Smart-u), Randomised Clinical Trial Protocol. Res Sq [Preprint]. 2023 Dec 2:rs.3.rs-3667486. doi: 10.21203/rs.3.rs-3667486/v1. Update in: Neuropsychiatr Dis Treat. 2024 Nov 25;20:2277-2286. doi: 10.2147/NDT.S490050. PMID: 38077080; PMCID: PMC10705707.