Epilepsy
Conditions
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, 6, 12, and 18 months (if warranted). This project will also build clinical and research capacity for epilepsy work in western Kenya.
Interventions
BEHAVIORALTask 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
Sponsors
University of Virginia
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VOILS: Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence) | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liverpool Seizure Severity Scale 2.0 | Baseline; 1 year | 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) |
| QOLIE-31 | Baseline; 1 year | 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. |
| Kilifi Epilepsy Perceived Stigma Scale (KESS) | Baseline; 1 year | 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. |
| European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) | Baseline, 1 year | 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. |
| Seizure-safety checklist | Each visit | Using a 5-item questionnaire, participants will be assessed for any seizure-related injury, including type of injury and duration. |
| Mortality | 1 year | Death by the end of 1-year follow-up. It will be reported as Alive: yes/no |
Countries
Kenya
Contacts
CONTACTJane von Gaudecker, PhD
CONTACTChrispine Oduor, MBChB
PRINCIPAL_INVESTIGATORJane von Gaudecker, PhD
Indiana University
Outcome results
None listed