NCT06264700Completed
Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 12 Jan 2024
- Start date
- 11 Jul 2024
- Primary completion date
- 23 Jul 2026
- Lead sponsor
- Nationwide Children's Hospital
- Diseases
- Sickle cell disease
- NCT number
- NCT06264700
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 11 Jul 2024 to the primary completion date, 23 Jul 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 11 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lurie Children's Hospital Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Hasbro Children's Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.