Bridging the Childhood Epilepsy Treatment Gap in Africa (BRIDGE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,672
- 试验地点
- 3
- 主要终点
- Percentage Seizure-free for 6 Months, or Longer, Measured at 24 Months After Enrollment
研究概览
简要总结
About half of the world's children with epilepsy do not receive treatment - known as the epilepsy treatment gap - with significantly higher rates (67%-90%) in low- and middle-income countries (LMICs). We will conduct the first cluster-randomized clinical trial (cRCT) to determine the efficacy, implementation, and cost-effectiveness of a novel intervention shifting childhood epilepsy care to epilepsy-trained community health extension workers in an effort to close the epilepsy treatment gap. This research will provide information to help extend epilepsy treatment to children in LMICs and worldwide who suffer from untreated seizures.
详细描述
Epilepsy is the most common severe neurological disorder among children. Most children with epilepsy, if treated, can live normal lives. Yet among the world's children living with epilepsy, about 80% of whom reside in low- and middle-income countries (LMICs), about half do not receive treatment; this is described as "the childhood epilepsy treatment gap." Among the LMICs of Africa, the childhood epilepsy treatment gap is about 67%-90% - unchanged for over twenty years. Although the World Health Organization (WHO) and other health agencies recommend that the epilepsy treatment gap be bridged by task shifting epilepsy care to community health extension workers (CHWs) in primary care settings, this recommendation has not been implemented on a large scale. This failure to scale up task shifting in epilepsy care is due to (a) inadequate evidence of efficacy of task-shifted epilepsy care, (b) a lack of methods and tools for implementing epilepsy task shifting, (c) inadequate understanding of task-shifted epilepsy care barriers, and (d) a lack of cost-effectiveness data for health policymakers. CHWs providing task-shifted epilepsy care must identify children with epilepsy, disadvantaged by stigma and unknown to the healthcare system, who are without access to neurologists or electroencephalograms (EEGs). An epilepsy screening tool in the local language (e.g., Hausa) is therefore essential for epilepsy diagnosis, seizure type classification, and medical management. Hausa, the most commonly spoken language in west Africa, with over 120 million Hausa speakers, is used in daily life, commerce, and education; our proposed study will be conducted in three major cities in Hausa-speaking Africa.
Funded by an R21 grant (R21TW010899) in preparation for this cluster-randomized clinical trial (cRCT), we developed and piloted in Kano, Nigeria (a) a scalable epilepsy training program for CHWs, (b) an epilepsy community education program in Hausa to facilitate screening, diagnosis and treatment; and (c) an epilepsy data management system. We also (d) validated an epilepsy screening, diagnosis, and seizure classification tool in Hausa, (e) demonstrated feasibility of screening and enrolling children in a cRCT of task-shifted epilepsy care, and (f) piloted a task-shifted epilepsy diagnosis and management protocol. We will now conduct the first cRCT of task-shifted childhood epilepsy care in Africa with the following specific aims:
Conduct a non-inferiority cRCT of a task-shifted childhood epilepsy care protocol compared to enhanced usual care (EUC) in three Hausa-speaking cities in northern Nigeria. We will enroll a maximum of 1800 children (age 6 mo, <18 yrs) with epilepsy across 60 randomly selected primary healthcare centers (PHCs) in Kano (30 PHCs), Kaduna (16 PHCs) and Zaria (14 PHCs). PHCs will be randomly assigned to intervention (task-shifted to CHWS childhood epilepsy care; 30 PHCs) or EUC (referral to a physician for epilepsy management; 30 PHCs). Primary outcome: we hypothesize that the proportion of children seizure-free for ≥ 6 months at 24 months follow-up (primary outcome) will be similar in the intervention and EUC arms. Secondary outcomes at 24 months include (a) percent seizure reduction from baseline, (b) time to next seizure after 3 months seizure-free, and (c) accuracy of epilepsy diagnosis and seizure type classification by CHWs compared to assessments by physician epilepsy specialists, blinded to the randomization arm.
Additional studies of (1) socio-behavioral and implementation outcomes of implementing task-shifted epilepsy care among providers, parents/guardians and patients in the cRCT, and (2) the cost-effectiveness of the task-shifted epilepsy care intervention will performed/completed after completion of the cRCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Four epilepsy-trained physicians served as blinded physicians for the study, and evaluated every study subjects in both arms at 1, 6, 12, 18, and 24 months after enrollment. These blinded physicians had no other role in the cRCT other than to serve as the gold standard for the diagnosis of epilepsy, to determine study subjects' seizure frequency, potential anti-seizure medication (ASM)-related adverse events and monitored each child's exam and development. Blinded physicians entered clinical data into case report forms on their study-dedicated android tablet computers, with data uploaded to the study data office and the data coordinating center. Parents/guardians, study staff and co-investigators were instructed to not disclose the study arm of study subjects with blinded physicians. Blinded physicians were not included in study meetings, did not have access to study offices or study data, and met separately with study principal investigators to address any study related issues.
入排标准
- 年龄范围
- 6 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resident of Kano or Kaduna states and living in the Kano, Zaria, or Kaduna metropolitan areas of northern Nigeria
- •Parent or guardian provided informed consent for the screening questionnaire given to the parent/guardian
- •Parent or guardian informed consent, plus assent for children >7 years able to provide assent, for epilepsy diagnostic evaluation if the screening for possible epilepsy is positive
- •Diagnosed with possible epilepsy through initial screening, and then diagnosed with epilepsy upon further evaluation by an epilepsy-trained CHW working with the BRIDGE project, who may consult a BRIDGE physician for diagnostic questions
- •Parent or guardian provided consent, and assent for children >7 years able to provide assent, for enrollment in the cRCT of task-shifted epilepsy care versus enhanced physician epilepsy care
排除标准
- •Children who have previously been diagnosed with epilepsy and are currently enrolled in other care and treatment, or who have been treated for epilepsy within three months prior to screening
- •Children who are currently receiving care by a neurologist or neurosurgeon for a serious brain disorder (e.g., brain tumor, stroke)
- •Lack of informed consent, and/or lack of assent from children >7 years who are able to provide assent.Inability of the parent or guardian to communicate with healthcare providers in either Hausa or English
- •Any child who screens positive for epilepsy, has epilepsy upon clinical evaluation, but does not live in Kano, Zaria, and Kaduna, and who is in the judgement of the parents and/or BRIDGE staff to be unable to comply with the study visits because of travel distance from home.
研究组 & 干预措施
Task-shifted arm
In the task-shifted care arm (TSC), all children will be prescribed anti-seizure medication and receive follow-up care from a community health worker (CHW), with a physician consult available to the CHW as needed.
干预措施: Task-shifting epilepsy care to epilepsy-trained community health workers (CHWs) (Other)
Enhanced usual care arm
In the enhanced usual care arm (EUC), all children will be prescribed anti-seizure medication and receive follow-up care from a physician. A CHW collecting standardized data will mirror the intervention arm. In addition, the CHW will enhance the physician care by assisting parents navigate the healthcare system.
干预措施: Enhanced usual care for epilepsy (EUC) (Other)
结局指标
主要结局
Percentage Seizure-free for 6 Months, or Longer, Measured at 24 Months After Enrollment
时间窗: Outcome measured 18 months to 24 months after enrollment
Percentage of children in each arm of the study who were seizure-free for 6 months, or longer, measured specifically at 24 months after enrollment. Physicians with expertise in epilepsy, blinded as to study arm, utilized review of seizure diaries maintained by parents plus medical history, to determine whether each child had been seizure free for six months, or longer, 24 months after enrollment in the cluster RCT.
次要结局
- 75% or Greater Reduction in Seizure Frequency as Determined by the Blinded Physician at 24 Months Follow-up Visit(Outcome measured 18 months to 24 months after enrollment)
- Seizure Freedom for Six Months or Longer in Response to the First Prescribed Anti-epileptic Drug(Outcome measured from prescription of the first anti-seizure medication during 24 months after enrollment)
- Diagnostic Accuracy(Diagnostic accuracy measured at 1 month after enrollment.)
- Mortality(Deaths measured for 25 months after enrollment.)
- Number of Children Who Experienced Status Epilepticus(Baseline to 24 months after enrollment)
- Morbidity(Morbidity outcomes measured for 24 months after enrollment.)
- Number of Children for Whom an EEG Was Ordered(Baseline to 24 months after enrollment)
- Task-shifted Protocol Adherence(Baseline to 24 months after enrollment.)
- Anytime 6-month Seizure-free Interval(Baseline to 24 months after enrollment.)
研究者
Edwin Trevathan
Professor of Neurology and Pediatrics, Vanderbilt Institute for Global Health
Vanderbilt University Medical Center