Using video to help children and teens with sickle cell disease take their hydroxyurea medication
Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness
This study tests if using videos can help kids and teens with sickle cell disease remember to take their hydroxyurea medication better than just regular reminders.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 11 Years and up |
| Sex | All |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Trial ID | NCT06264700 on ClinicalTrials.gov |
What this trial studies
This study focuses on caregivers of young children and adolescents with sickle cell disease who are prescribed hydroxyurea. It compares the effectiveness of video directly observed therapy (VDOT) to an attention control in improving medication adherence. Participants will use electronic monitors to track their medication intake and complete surveys about their experiences. The study aims to enhance long-term adherence and understand patient and family preferences regarding treatment monitoring.
Who should consider this trial
Good fit: Ideal candidates include English-speaking caregivers of children aged 1-10 with sickle cell disease or adolescents aged 11-25 who have been on hydroxyurea for at least 180 days.
Not a fit: Patients who have participated in previous VDOT studies or those receiving multiple sickle cell disease treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve medication adherence among children and adolescents with sickle cell disease, leading to better health outcomes.
How similar studies have performed: Other studies using similar adherence monitoring techniques have shown promise, but this specific approach with VDOT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois and 2 other locations
- Lurie Children's Hospital — Chicago, Illinois, United States (Not_yet_recruiting)
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
- Hasbro Children's Hospital — Providence, Rhode Island, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Susan Creary, MD, MSc — Nationwide Children's Hospital
- Study coordinator: Susan Creary, MD, MSc
- Email: susan.creary@nationwidechildrens.org
- Phone: (614) 722-3550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.