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NCT06623994 | NOT YET RECRUITING | Epilepsy

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

Indiana University

Information provided by (Responsible Party):

Jane von Gaudecker

Brief Summary:

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.

Condition or disease

Epilepsy

Intervention/treatment

Task sharing with Epilepsy Medical Record Systems

Phase

NA

Detailed Description:

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, 12 and 18 months (if warranted). This project will also build clinical and research capacity for epilepsy work in western Kenya.

Study Type : INTERVENTIONAL
Estimated Enrollment : 530 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Bridging the Treatment Gap by Expanding Access to Care for People with Epilepsy in Kenya (BEACON)
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2028-10
Estimated Study Completion Date : 2029-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 12 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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.
Exclusion Criteria
  • * 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)
Bridging the Treatment Gap by Expanding Access to Care for People with Epilepsy in Kenya (BEACON)

Location Details

NCT06623994

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Locations

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