EpilepsyBEACONNCT06623994
Bridging the Treatment Gap by Expanding Access to Care for People With Epilepsy in Kenya (BEACON)
A study testing Task sharing with Epilepsy Medical Record Systems in people with Epilepsy, run by University of Virginia at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Task sharing with Epilepsy Medical Record Systems
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteKenya
- Study dates
- 4 Aug 2025to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chrispine Oduor, MBChB contact
Kenya1 site, 1 recruiting
- Recruiting
Moi University
Eldoret
Lilian Lusimbo, 254728421728, llusimbo@ampath.or.ke
About this study
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Task sharing with Epilepsy Medical Record Systems
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task sharing with Epilepsy Medical Record SystemsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Task sharing with Epilepsy Medical Record Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (6)
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Each visit
Mortality
Death by the end of 1-year follow-up. It will be reported as Alive: yes/no
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start4 Aug 2025
- Primary completionFeb 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane R. Von Gaudecker, University of Virginia
- Investigators
- Jane von Gaudecker, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623994
- Sponsor's protocol ID
- 23924
- Other IDs
- R01NS134056
- Acronym
- BEACON
- Status last verified
- May 2026
- First submitted
- 24 Sep 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging the Treatment Gap by Expanding Access to Care for People With Epilepsy in Kenya (BEACON)
- ClinicalTrials.gov ID
- NCT06623994
- Acronym / sponsor ID
- BEACON / 23924
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 6, 12, and 18 months (if warranted).
This project will also build clinical and research capacity for epilepsy work in western Kenya.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Task sharing with Epilepsy Medical Record SystemsThose 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Task sharing with Epilepsy Medical Record SystemsTraining 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 | Behavioural | BEACON Group |
Primary outcome
VOILS: Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence)
Time frame: Baseline; 1 year
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
Antiseizure medication blood levels
Time frame: Baseline; 1 year
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.
Number of participants retained in care
Time frame: 1 year
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.
6 secondary outcomes
Liverpool Seizure Severity Scale 2.0
Time frame: Baseline; 1 year
QOLIE-31
Time frame: Baseline; 1 year
Kilifi Epilepsy Perceived Stigma Scale (KESS)
Time frame: Baseline; 1 year
European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
Time frame: Baseline, 1 year
Seizure-safety checklist
Time frame: Each visit
Mortality
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chrispine Oduor, MBChB contact
Jane von Gaudecker, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task sharing with Epilepsy Medical Record Systems in people with Epilepsy, run by University of Virginia at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jane von Gaudecker, PhD (317-278-2758, jvongaud@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VOILS: Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence) (time frame: Baseline; 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.