Status:
ACTIVE_NOT_RECRUITING
Bridging the Childhood Epilepsy Treatment Gap in Africa
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Aminu Kano Teaching Hospital
Ahmadu Bello University Teaching Hospital
Conditions:
Epilepsy
Eligibility:
All Genders
6-16 years
Phase:
NA
Brief Summary
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)....
Detailed Description
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% ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT04290975
Start Date
June 16 2020
End Date
May 31 2025
Last Update
July 8 2024
Active Locations (3)
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1
Federal Neuro-Psychiatric Hospital
Kaduna, Nigeria
2
Aminu Kano Teaching Hospital
Kano, Nigeria
3
Ahmadu Bello University Teaching Hospital
Zaria, Nigeria