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

NCT06623994 | Recruiting DMC

• 2 other identifiers: 23924R01NS134056
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Liverpool Seizure Severity Scale 2.0

  Baseline; 1 year

• QOLIE-31

  Baseline; 1 year

• Kilifi Epilepsy Perceived Stigma Scale (KESS)

  Baseline; 1 year

• European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)

  Baseline, 1 year

• Seizure-safety checklist

  Each visit

Study Arms (2)

Usual care Group

NO INTERVENTION

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.

BEACON Group

EXPERIMENTAL

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

Interventions

Task sharing with Epilepsy Medical Record Systems BEHAVIORAL

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

BEACON Group

Eligibility Criteria

• Age: 12 Years+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Moi University

Eldoret, Kenya

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jane von Gaudecker, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane von Gaudecker, PhD

CONTACT

317-278-2758; jvongaud@iu.edu

Chrispine Oduor, MBChB

CONTACT

drowuorchris@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 2, 2024
• Study Start: August 4, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

KE (1)