Self-management Intervention for Reducing Epilepsy Burden Among Adult Ugandans With Epilepsy (Smart-u), Randomised Clinical Trial Protocol.
Epilepsy
Self-Management
intervention
targeted management
Journal
Research square
Titre abrégé: Res Sq
Pays: United States
ID NLM: 101768035
Informations de publication
Date de publication:
02 Dec 2023
02 Dec 2023
Historique:
pubmed:
11
12
2023
medline:
11
12
2023
entrez:
11
12
2023
Statut:
epublish
Résumé
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. 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. 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. NCT06139198. 14
Sections du résumé
Background
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
NCT06139198.
Date of registration
UNASSIGNED
14
Identifiants
pubmed: 38077080
doi: 10.21203/rs.3.rs-3667486/v1
pmc: PMC10705707
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT06139198']
Types de publication
Preprint
Langues
eng
Subventions
Organisme : NINDS NIH HHS
ID : R01 NS129041
Pays : United States
Déclaration de conflit d'intérêts
Competing interests The authors declare that they have no competing interests.
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