Bridging the Treatment Gap by Expanding Access to Care for People With Epilepsy in Kenya (BEACON)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Task sharing with Epilepsy Medical Record Systems.
- Who it may be relevant to
- Registry conditions: Epilepsy. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kenya
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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, 6, 12, and 18 months (if warranted).
This project will also build clinical and research capacity for epilepsy work in western Kenya.
Interventions
- Behavioral 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
Primary outcome measures
- VOILS: Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence) [Time frame: Baseline; 1 year]
- Antiseizure medication blood levels [Time frame: Baseline; 1 year]
- Number of participants retained in care [Time frame: 1 year]
Secondary outcome measures (6)
- Liverpool Seizure Severity Scale 2.0 [Time frame: Baseline; 1 year]
- QOLIE-31 [Time frame: Baseline; 1 year]
- Kilifi Epilepsy Perceived Stigma Scale (KESS) [Time frame: Baseline; 1 year]
- European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) [Time frame: Baseline, 1 year]
- Seizure-safety checklist [Time frame: Each visit]
- Mortality [Time frame: 1 year]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Kenya · 1 center
- Moi University — Eldoret
Identifiers
NCT: NCT06623994 · 23924 · R01NS134056