NCT06264700 Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness
| NCT ID | NCT06264700 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nationwide Children's Hospital |
| Condition | Sickle Cell Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-07-11 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-07-11 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is for caregivers of young children with sickle cell disease and adolescents with sickle cell disease who are currently prescribed hydroxyurea and are receiving care at one of the study sites. The study will assess retention and engagement during a pilot randomized control trial comparing video directly observed therapy (VDOT) to attention control. We also hope to understand more about patient and family preferences longer-term adherence monitoring and intervention. Participants will use an electronic adherence monitor (provided by the study team) to measure how often they are taking their hydroxyurea. Participants will also be asked to complete questionnaires throughout the study period to provide information about their expectations for, experience with, and satisfaction with the study materials.
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.
Contact & Investigator
Susan Creary, MD, MSc
PRINCIPAL INVESTIGATOR
Nationwide Children's Hospital
Frequently Asked Questions
Who can join the NCT06264700 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, studying Sickle Cell Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06264700 currently recruiting?
Yes, NCT06264700 is actively recruiting participants. Contact the research team at susan.creary@nationwidechildrens.org for enrollment information.
Where is the NCT06264700 trial being conducted?
This trial is being conducted at Chicago, United States, Columbus, United States, Providence, United States.
Who is sponsoring the NCT06264700 clinical trial?
NCT06264700 is sponsored by Nationwide Children's Hospital. The principal investigator is Susan Creary, MD, MSc at Nationwide Children's Hospital. The trial plans to enroll 60 participants.
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