Status:
COMPLETED
Shared-Decision Making for Hydroxyurea
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Sickle Cell Anemia
Children, Only
Eligibility:
All Genders
1-5 years
Phase:
NA
Brief Summary
The goal of the study is to understand how best to help parents of young children with sickle cell disease and their clinicians have a shared discussion about hydroxyurea (one that takes into account ...
Detailed Description
Sickle cell disease (SCD) is a genetic blood disorder that places children at risk for serious medical complications, early morbidity and mortality, and high healthcare utilization. In the U.S., SCD p...
Eligibility Criteria
Inclusion
- Diagnosis: sickle cell disease
- Age: birth-5 years, inclusive
- Eligible for hydroxyurea (genotype SS, Sβ0Thal or other genotype + clinical complications)
- Child's parent, legal guardian, or designated decision maker (caregiver) must participate in both study visits
- Child's parent, legal guardian, or designated decision maker (caregiver) must able to read, understand, and speak English
Exclusion
- Parent/legal guardian has previously been approached OR made a decision about whether to initiate hydroxyurea.
- Any and all other diagnoses or conditions which, in the opinion of the site investigator or hematologist, would prevent the patient from being a suitable candidate for the study.
Key Trial Info
Start Date :
July 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT03442114
Start Date
July 12 2018
End Date
February 28 2022
Last Update
June 13 2025
Active Locations (11)
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1
UCSF Beinoff Children's Hospital and Research Center at Oakland
Oakland, California, United States, 94609
2
Nemours Children's Health
Wilmington, Delaware, United States, 19803
3
Howard University
Washington D.C., District of Columbia, United States, 20060
4
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611