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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Page 1 of 3 (11 locations)

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