Clinical trial NCT06623994: Bridging the Treatment Gap by Expanding Access to Care for People with Epilepsy in Kenya (BEACON)
Official title: Bridging the Treatment Gap by Expanding Access to Care for People with Epilepsy in Kenya (BEACON)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 530
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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)

Primary outcomes:
measure: Morisky Medication Adherence Scale (MMAS-8)
timeFrame: Baseline; 1 year; upto 18-months-if warranted
measure: Antiseizure medication blood levels
timeFrame: Baseline; 1 year; upto 18-months-if warranted
measure: Number of participants retained in care
timeFrame: 1 year; upto 18-months-if warranted
Secondary outcomes:
measure: Liverpool Seizure Severity Scale 2.0
timeFrame: Baseline; 1 year; upto 18-months-if warranted
measure: World Health Organization Quality of Life (WHOQOL-BREF)
timeFrame: Baseline; 1 year; upto 18-months-if warranted
measure: Kilifi Epilepsy Perceived Stigma Scale (KESS)
timeFrame: Baseline; 1 year; upto 18-months-if warranted
measure: European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
timeFrame: Baseline, one month, 6 months, 1 year, 18 months (if warranted)
Other outcomes:
measure: Seizure-safety checklist
timeFrame: Each visit
measure: Mortality
timeFrame: 1 year
Locations:
Study officials:
affiliation: Indiana University
name: Jane von Gaudecker, PhD
role: PRINCIPAL_INVESTIGATOR
References: