Self-Management Intervention for Reducing Epilepsy Burden Among Adult Ugandans with Epilepsy (SMART-U): Randomised Clinical Trial Protocol

Scovia Nalugo Mbalinda; Mark Kaddumukasa; Josephine Nambi Najjuma; Doreen R Birungi; Martin Ntambi Kaddumukasa; Jennifer B Levin; Carolyn Harmon Still; Christopher J Burant; Avani C Modi; Elly T Katabira; Martha Sajatovic

doi:10.2147/NDT.S490050

Self-Management Intervention for Reducing Epilepsy Burden Among Adult Ugandans with Epilepsy (SMART-U): Randomised Clinical Trial Protocol

Neuropsychiatr Dis Treat. 2024 Nov 25:20:2277-2286. doi: 10.2147/NDT.S490050. eCollection 2024.

Authors

Affiliations

¹ Department of Nursing, College of Health Sciences, Makerere University, Kampala, Uganda.
² Department of Medicine, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.
³ Department of Nursing, Mbarara University of Science and Technology, Mbarara, Uganda.
⁴ Department of Medicine, Mulago Hospital, Kampala, Uganda.
⁵ Neurological and Behavioral Outcomes Center, University Hospitals Cleveland Medical Center & Case Western Reserve University School of Medicine, Cleveland, OH, 44106, USA.
⁶ Louis Stokes VA Medical Center, Geriatric Research Education, and Clinical Center, Cleveland, OH, 44106, USA.
⁷ Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, 44106, USA.
⁸ Cincinnati Children, S Hospital Medical Center, Cincinnati, Ohio, USA.

^# Contributed equally.

Abstract

Background: People of all ages are affected by epilepsy, a prevalent chronic brain illness that is primarily found in underdeveloped nations. It is very necessary to implement epilepsy self-management techniques to support individuals with epilepsy in order to impact outcomes related to epilepsy. The purpose of this 2-site randomised controlled experiment is to investigate this further, based on encouraging preliminary evidence.

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.

Trial registration number trn: NCT06139198.

Date of registration: November142023.

Keywords: epilepsy; intervention; self-management; targeted management.

Associated data

ClinicalTrials.gov/NCT06139198

Grants and funding

Research reported in this publication was supported by the National Institute Of Neurological Disorders And Stroke of the National Institutes of Health under Award Number R01NS129041 to Mark Kaddumukasa and Martha Sajatovic. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.