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NCT03431935 · ClinicalTrials.gov registry record

Predictors and Outcomes in Patients With Sickle Cell Disease

A clinical trial, sponsored by St. Jude Children's Research Hospital.

Completed
Registry status
94
Enrollment target

NCT03431935: Completed study, sponsored by St. Jude Children's Research Hospital.

NCT03431935 is a clinical trial that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 94 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03431935 has completed, sponsored by St. Jude Children's Research Hospital.

COMPLETED
Registry status
94 participants
Enrollment target

Study Summary

Children with sickle cell disease (SCD) are living longer with the advent of medical advances such as prophylactic penicillin, chronic transfusion, and hydroxyurea. Despite greater longevity in SCD, the period following the transition from pediatric to adult care is critical; youth aged 18-30 years are at high risk for mortality and have high rates of healthcare utilization, leading to high healthcare costs. As such, health care transition (HCT) programs have been created to prepare patients for adult-centered care and subsequently, improve health outcomes. However, very few programs have been evaluated for effectiveness in achieving optimal health outcomes in SCD. This paucity of program evaluation is attributed to a lack of identifiable predictors and outcomes. Researchers at St. Jude Children's Research Hospital want to identify factors and patterns of successful HCT. This information will be used to develop approaches to best evaluate HCT interventions and identify areas of improvement of HCT programming. PRIMARY OBJECTIVE: Describe hospital utilization, treatment adherence, and health-related quality of life in a cohort of patients with sickle cell disease (SCD) who will transfer to adult care during the study period. SECONDARY OBJECTIVE: Examine the associations between various factors and health care transition (HCT) outcomes.

Primary Outcome

The primary objective will utilize data collected at age 19 years, 0 months (±2 months), the age participants will have transferred to adult care. This data will come from participants enrolled between the ages of 17 years, 0 months and 19 years, 0 months.

Trial Details

FieldValue
Enrollment Target 94 participants
Start Date 2018-07-31
Est. Completion 2023-05-26

What the finished NCT03431935 record still lists

NCT03431935 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 94 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT03431935 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03431935 about?

NCT03431935 is a clinical study titled "Predictors and Outcomes in Patients With Sickle Cell Disease". Children with sickle cell disease (SCD) are living longer with the advent of medical advances such as prophylactic penicillin, chronic transfusion, and hydroxyurea. Despite greater longevity in SCD, the period following the transition from pediatric to adult care is critical; youth aged 18-30 years ...

What is the current status of trial NCT03431935?

This trial is currently completed. The enrollment target is 94 participants. The study started on 2018-07-31. Estimated completion is 2023-05-26.

Who is sponsoring clinical trial NCT03431935?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03431935, the US trial registry maintained by the National Library of Medicine. NCT03431935 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.