Bridging the Treatment Gap by Expanding Access to Care for People With Epilepsy in Kenya (BEACON)

Обзор

This cluster randomized trial aims to learn about the effectiveness of task-sharing supported by an epilepsy medical records system (EMRS) (hereafter referred to as BEACON) with patient-tracking data in improving treatment adherence and retention in care in people with epilepsy in western Kenya.

Подробное описание

Epilepsy is a serious neurological condition and a major cause of morbidity and mortality. Globally, epilepsy prevalence is highest in sub-Saharan Africa, and Kenya has a high disease burden. Delay in treatment initiation and non-adherence increase disease-related burden in terms of low quality of life, high healthcare costs, risk for seizure-related injuries, and premature death

The BEACON intervention is grounded in existing evidence-based intervention. Task-sharing, an intervention advocated by the World Health Organization and the Institute of Medicine. Researchers will compare patients receiving the BEACON intervention to those receiving usual care to see if there are any differences in treatment adherence and retention in care between the groups. Researchers will test BEACON's ability to: (1) improve care retention and treatment adherence; and (2) reduce seizure severity and perceived stigma and improve quality of life (QoL). The cost-effectiveness of the intervention will also be assessed. Data will be collected at baseline, 6, 12, and 18 months (if warranted).

This project will also build clinical and research capacity for epilepsy work in western Kenya.

Вмешательства

• Поведенческое Task sharing with Epilepsy Medical Record Systems
  Training multiple cadres of healthcare workers in epilepsy treatment and management to enable a team-based approach to address access to care. Task sharing will be supported by epilepsy medical records system with patient tracking data to support care retention

Первичные конечные точки

• VOILS: Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence) [Срок оценки: Baseline; 1 year]
• Antiseizure medication blood levels [Срок оценки: Baseline; 1 year]
• Number of participants retained in care [Срок оценки: 1 year]

Вторичные конечные точки (6)

• Liverpool Seizure Severity Scale 2.0 [Срок оценки: Baseline; 1 year]
• QOLIE-31 [Срок оценки: Baseline; 1 year]
• Kilifi Epilepsy Perceived Stigma Scale (KESS) [Срок оценки: Baseline; 1 year]
• European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) [Срок оценки: Baseline, 1 year]
• Seizure-safety checklist [Срок оценки: Each visit]
• Mortality [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Individuals ≥12 years
• Residents of Busia or Trans Nzoia County
• Diagnosed with possible epilepsy through initial screening and confirmed diagnosis by an epilepsy-trained professional with the BEACON project or physician
• Have a diagnosis of epilepsy but are not adherent to antiseizure medication treatment.

Критерии исключения

• Individuals receiving care from a neurosurgeon or neurologist for a serious brain disorder
• Unable or unwilling to provide voluntary informed consent or assent (12-18 years)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Kenya · 1 центр

• Moi University — Eldoret

Идентификаторы

NCT: NCT06623994 · 23924 · R01NS134056

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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