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Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness - Trial NCT06264700

Access comprehensive clinical trial information for NCT06264700 through Pure Global AI's free database. This phase not specified trial is sponsored by Nationwide Children's Hospital and is currently Not yet recruiting. The study focuses on Sickle Cell Disease. Target enrollment is 60 participants.

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NCT06264700
Not yet recruiting
behavioral
Trial Details
ClinicalTrials.gov โ€ข NCT06264700
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Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness

Study Focus

Sickle Cell Disease

Video Directly Observed Therapy (VDOT)

Interventional

behavioral

Sponsor & Location

Nationwide Children's Hospital

Chicago,Providence, United States of America

Timeline & Enrollment

N/A

Mar 01, 2024

Dec 01, 2025

60 participants

Primary Outcome

Retention Rate,Sustained Engagement,Electronic Adherence

Summary

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.

ICD-10 Classifications

Sickle-cell disorders
Other sickle-cell disorders
Sickle-cell trait
Sickle-cell anaemia with crisis
Sickle-cell anaemia without crisis

Data Source

ClinicalTrials.gov

NCT06264700

Non-Device Trial