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

NCT ID: NCT06623994

Last Updated: 2025-08-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 530 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-04
• Study Completion Date: 2029-08-31

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.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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 \& 5, medical officer in level 5), including regular consultation, vital signs, clinical history, physical examination, and prescriptions as required to control seizures.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Task sharing with Epilepsy Medical Record Systems

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Jane von Gaudecker

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jane von Gaudecker, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Moi University

Eldoret, , Kenya

Site Status: RECRUITING

Countries

Kenya

Central Contacts

Jane von Gaudecker, PhD

Role: CONTACT

jvongaud@iu.edu

317-278-2758

Chrispine Oduor, MBChB

Role: CONTACT

drowuorchris@gmail.com

Facility Contacts

Lilian Lusimbo

Role: primary

llusimbo@ampath.or.ke

254728421728

Other Identifiers

23924

Identifier Type: -

Identifier Source: org_study_id