ArticleResearch square2023
Self-management Intervention for Reducing Epilepsy Burden Among Adult Ugandans With Epilepsy (Smart-u), Randomised Clinical Trial Protocol.
Article in Research square, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06139198 (Self-Management Intervention for Reducing Stroke Burden Among Ugandans With Epilepsy), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Self-Management Intervention for Reducing Stroke Burden Among Ugandans With Epilepsy
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11 authors at 5 institutions in 2 countries.
Funding
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. 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 their 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. Trial Registration Number TRN: NCT06139198. Date of registration: 14
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