Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2025-12-26 @ 12:15 PM
NCT ID:
NCT06264700
Eligibility Criteria:
Inclusion:
Adult caregivers will be eligible if they:
* Are English speaking.
* Have a child who is 1-10 years of age with SCD (any genotype) who has been prescribed hydroxyurea for at least 180 days prior to enrollment.
* Note: Caregivers who have multiple children meeting criteria will only be able to enroll once.
Adolescents (\>11 years at enrollment) are eligible if they:
* Are English speaking.
* Are 11-25 years of age.
* Have a diagnosis of SCD (any genotype) and have been prescribed hydroxyurea for at least 180 days prior to enrollment.
Exclusion:
* Adolescents and caregivers of younger children who participated in the previous VDOT study will be excluded.
* Adolescents and caregivers of younger children receiving multiple SCD modifying treatments (e.g., chronic transfusions or L-glutamine) will be excluded.
Randomization: enrolled subjects will be eligible for randomization if they open their electronic adherence monitoring device at home at least once during the run-in period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Study:
NCT06264700
Study Brief:
Protocol Section:
NCT06264700