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

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: Task sharing with Epilepsy Medical Record Systems

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.

• Study Type: Interventional
• Enrollment (Estimated): 650
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jane von Gaudecker, PhD; Phone Number: 317-278-2758; Email: jvongaud@iu.edu
• Study Contact Backup: Name: Chrispine Oduor, MBChB; Email: drowuorchris@gmail.com

Study Locations

• Kenya
  • Eldoret, Kenya
    • Recruiting
    • Moi University
    • Contact: Lilian Lusimbo; Phone Number: 254728421728; Email: llusimbo@ampath.or.ke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BEACON Group; Those randomized to the BEACON group will receive care from clinicians who received training in epilepsy management and care. Epilepsy management tasks will be shared among the trained clinicians (e.g., nurses will offer care at all levels). ASMs used will be the same as usual care. Details about the patient will be entered in the medical records system to help with return appointment patient tracking and follow-up. Two days before the follow-up appointment date, participants will be contacted via phone or text messaging to remind them about the follow-up appointments. If participants cannot be contacted via phone a day before the appointment, the local CHW will make attempts to contact them at home. Participants who miss the appointment will be contacted again, and another appointment date will be given.	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
No Intervention: Usual care Group; The current standard of care will be delivered. Care will be provided to the individual at the health facility by a clinician (clinical officer in levels 3, 4), including regular consultation, vital signs, clinical history, physical examination, and prescriptions as required to control seizures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antiseizure medication blood levels	Blood concentration of antiseizure medications will be measured as a direct method of assessing medication adherence. A blood sample (2ml) will be collected to measure adherence.	Baseline; 1 year
VOILS: Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence)	Changes in self-reported adherence to antiseizure medication at one year from baseline as assessed using a two-domain self-report measure of medication non-adherence tool	Baseline; 1 year
Number of participants retained in care	For the BEACON group, an electronic medical record system will be used to track follow-up status, patient reminders and retention in care. For usual care, participant follow-up status will be recorded in the patient chart to mimic real-world practice. Retention in care status will be recorded as yes/no. Retention in care will be defined as completing at least 4 routine epilepsy follow-ups within a 12 month period.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure-safety checklist	Using a 5-item questionnaire, participants will be assessed for any seizure-related injury, including type of injury and duration.	Each visit
Mortality	Death by the end of 1-year follow-up. It will be reported as Alive: yes/no	1 year
Liverpool Seizure Severity Scale 2.0	NINDS Common Data Elements tool to measure perception of seizure severity. The 12-item tool measures the number of seizures and how the patient rates its severity. The tool also measures the nature of their seizures, frequency and the effects of their seizures. Total score is the sum of individual item scores, with higher scores indicating more severe or impactful seizures. The total score ranges from 0 (no seizures) to 100 (most severe possible)	Baseline; 1 year
QOLIE-31	The 31-item self-report questionnaire designed to assess the health-related quality of life of adults living with epilepsy. It evaluates seven key dimensions: seizure worry, overall quality of life, emotional well-being, energy/fatigue, cognitive functioning, medication effects, and social functioning. Responses are converted into a weighted score ranging from 0 to 100, where higher values indicate a better quality of life.	Baseline; 1 year
Kilifi Epilepsy Perceived Stigma Scale (KESS)	This 15-item scale which was developed in Kenyan setting, measures perceived stigma. Specifically, the tool assesses (1) not relating well with family members, 2) not being accepted by peers) and 3) not being taken seriously by other people. Each item is scored on a 3-point Likert scale, leading to a total possible score ranging from 0 to 30. Higher the score greater the perceived stigma.	Baseline; 1 year
European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)	The EQ-5D-3L tool will be used to estimate the impact of BEACON in terms of costs per quality-of-life years gained relative to usual care. The scale ranges from 0 to 100 with 100 being the best health.	Baseline, 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure-safety checklist	Using a 5-item questionnaire, participants will be assessed for any seizure-related injury, including type of injury and duration.	Each visit
Mortality	Death by the end of 1-year follow-up. It will be reported as Alive: yes/no	1 year

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Jane von Gaudecker, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: September 24, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 23924; R01NS134056 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No