The Afolabi Stroke Registry for Children and Young Adults With SCD in Northern Nigeria

Summary

Participation Requirements

Description

The study is a multi-center, prospective observational cohort study. Thus, it is designed to be a longitudinal registry of strokes in children and young adults with SCA in Nigeria. Participants will be recruited from multiple sites in Nigeria that agree to participate. This study does not entail off...

The study is a multi-center, prospective observational cohort study. Thus, it is designed to be a longitudinal registry of strokes in children and young adults with SCA in Nigeria. Participants will be recruited from multiple sites in Nigeria that agree to participate. This study does not entail offering any intervention; all data collected will be based on standard of care. As new information is obtained about the rate of stroke recurrence, risk factors for strokes, and best treatment for strokes in children and young adults with SCA, the site investigators will share this information with the participants in the registry and their parents. Children and young adults with SCA will be consented to participate in the Afolabi Stroke Registry after a diagnosis of a stroke has been made within 3 months of the event. To enhance retention, the Investigators developed strategies to reduce loss-to-follow-up, including clear written participant instructions, reimbursing patient transportation costs for follow-up visits outside standard care visits, and fortnightly study phone calls. Further, the Investigators will request the names, addresses, and phone numbers of two family members or friends who know how to reach the participant in the event of a missed appointment (this information will be kept at each site and will not be entered into the central database). A medical history and physical examination, magnetic resonance imaging/magnetic resonance angiography (MRI/MRA), and neurological examination will be completed prior to enrollment of participants to confirm their eligibility for the study. Data on patients' demographics, stroke risk factors, and severity of strokes using the National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements or modified Rankin scale at baseline and annually. Children and young adults with SCA will be consented to participate in the Afolabi Stroke Registry after a diagnosis of a stroke has been made within 3 months of the event. To enhance retention, the Investigators developed strategies to reduce loss-to-follow-up, including clear written participant instructions, reimbursing patient transportation costs for follow-up visits outside standard care visits, and fortnightly study phone calls. Further, the Investigators will request the names, addresses, and phone numbers of two family members or friends who know how to reach the participant in the event of a missed appointment (this information will be kept at each site and will not be entered into the central database).A medical history and physical examination, MRI/MRA, and neurological examination will be completed prior to enrollment of participants to confirm their eligibility for the study. Data on patients' demographics, stroke risk factors, and severity of strokes using the National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements or modified Rankin scale at baseline and annually. Each participant will be prospectively followed until at least 10 years. the Investigators will collect and record all acute neurological events (overt stroke and TIA) requiring hospitalization or emergency department visits during the study. Imaging and clinical data collected as part of standard care will be used for secondary analysis. Research information, including consent forms, questionnaires, and results of cognitive testing will be maintained in a secure fashion in research charts in a locked file room or locked file cabinet, or in a secure Research Electronic Data Capture (REDCap) database.

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