An interventional study of Task sharing with Epilepsy Medical Record Systems in Epilepsy, sponsored by University of Virginia. Recruiting at 1 site in Kenya. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by University of Virginia · Not applicable, Interventional, and Treatment
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.
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.
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's planned enrollment of 650 is above the median of 50 across 1,239 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →University of Virginia is the lead sponsor of 675 studies on the registry; 138 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1 year
Seizure-safety checklist
Using a 5-item questionnaire, participants will be assessed for any seizure-related injury, including type of injury and duration.
Time frame: Each visit
Mortality
Death by the end of 1-year follow-up. It will be reported as Alive: yes/no
Time frame: 1 year
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