Bridging the Treatment Gap by Expanding Access to Care for People With Epilepsy in Kenya (BEACON)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- VOILS: Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Task sharing with Epilepsy Medical Record Systems (Behavioral)
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), including regular consultation, vital signs, clinical history, physical examination, and prescriptions as required to control seizures.
结局指标
主要结局
VOILS: Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence)
时间窗: Baseline; 6-months, 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
时间窗: 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
时间窗: 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.
Antiseizure medication blood levels
时间窗: 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
时间窗: 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
次要结局
- Liverpool Seizure Severity Scale 2.0(Baseline; 6-months; 1 year)
- World Health Organization Quality of Life (WHOQOL-BREF)(Baseline; 6-months; 1 year)
- Kilifi Epilepsy Perceived Stigma Scale (KESS)(Baseline; 6-months; 1 year)
- European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)(Baseline, 6 months, 1 year)
- Seizure-safety checklist(Each visit)
- Mortality(1 year)
研究者
Jane R. Von Gaudecker
Associate Professor
University of Virginia