Bridging the Childhood Epilepsy Treatment Gap in Africa (BRIDGE)

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 1530

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of children in each arm of the study who are seizure-free

Secondary Outcome Measures

Name	Time	Method
75% reduction in seizure frequency;Seizure freedom (6 months or longer) in response to the first AED prescribed;Diagnostic accuracy among study subjects in both arms, determined by blinded physicians;Differences in mortality between study arms that cannot be explained by potential differences in disease severity;Difference in frequency of status epilepticus among children in both arms;Differences in morbidity, including neurodevelopmental morbidity, associated with epilepsy between study arms that emerged during the cRCT;Differences by study arm in number and type of diagnostic tests (e.g., MRIs, EEGs) ordered;Percentage adherence by CHWs to protocol in the task-shifted arm;6-month seizure-free interval at any point during follow-up;Comparison of care costs between task-shifted and enhanced usual care study arms

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