Bridging the Treatment Gap by Expanding Access to Care for People with Epilepsy in Kenya (BEACON)
- Conditions
- Epilepsy
- Interventions
- Behavioral: Task sharing with Epilepsy Medical Record Systems
- Registration Number
- NCT06623994
- Lead Sponsor
- Indiana University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 530
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BEACON Group Task sharing with Epilepsy Medical Record Systems 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.
- Primary Outcome Measures
Name Time Method Morisky Medication Adherence Scale (MMAS-8) Baseline; 1 year; upto 18-months-if warranted Changes in self-reported adherence to antiseizure medication at one year from baseline as assessed using the 8-item Morisky Medication adherence questionnaire. The responses will be Yes/No. Low adherence= less than 6 and high adherence =8.
Antiseizure medication blood levels Baseline; 1 year; upto 18-months-if warranted 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; upto 18-months-if warranted 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 at least 1 follow-up visit 6 months -1 year after first visit
- Secondary Outcome Measures
Name Time Method Liverpool Seizure Severity Scale 2.0 Baseline; 1 year; upto 18-months-if warranted 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 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)World Health Organization Quality of Life (WHOQOL-BREF) Baseline; 1 year; upto 18-months-if warranted The 26-item scale measures four domains related to quality of life: physical health, psychological, social relationships, and environment. The responses for each item are on a 5-point Likert scale. The raw scores are then transformed to a 0 to 100 scale for easier interpretation, with higher scores indicating better quality of life in that domain.
Kilifi Epilepsy Perceived Stigma Scale (KESS) Baseline; 1 year; upto 18-months-if warranted 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, one month, 6 months, 1 year, 18 months (if warranted) 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.