Actively Recruiting
Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness
Led by Nationwide Children's Hospital · Updated on 2025-04-08
60
Participants Needed
3
Research Sites
72 weeks
Total Duration
On this page
Sponsors
N
Nationwide Children's Hospital
Lead Sponsor
A
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Caregivers must be English speaking
- Caregivers must have a child aged 1 to 10 years with sickle cell disease (any genotype)
- Child must have been prescribed hydroxyurea for at least 180 days prior to enrollment
- Adolescents must be English speaking
- Adolescents must be between 11 and 25 years of age
- Adolescents must have sickle cell disease (any genotype)
- Adolescents must have been prescribed hydroxyurea for at least 180 days prior to enrollment
You will not qualify if you...
- Adolescents and caregivers who participated in the previous VDOT study
- Adolescents and caregivers of children receiving multiple sickle cell disease modifying treatments such as chronic transfusions or L-glutamine
- Subjects who do not open their electronic adherence monitoring device at home at least once during the run-in period are not eligible for randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Lurie Children's Hospital
Chicago, Illinois, United States, 60611
Not Yet Recruiting
2
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
3
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02903
Not Yet Recruiting
Research Team
S
Susan Creary, MD, MSc
CONTACT
N
Nate Goldfarb, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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