NCT03431935

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

July 31, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2023

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

3.5 years

First QC Date

February 7, 2018

Last Update Submit

February 4, 2026

Conditions

Keywords

Health Care TransitionAdolescentYoung Adult

Outcome Measures

Primary Outcomes (4)

  • Number of emergency room/hospital admissions in the previous 12 months

    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.

    Once, at age 19

  • Percent of clinic visits completed in the previous 12 months

    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.

    Once, at age 19

  • Percent hydroxyurea prescription refill rate

    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.

    Once, at age 19

  • Health-related quality of life as assessed by the PedsQL

    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.

    Once, at age 19

Eligibility Criteria

Age16 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants who meet eligibility criteria and have a pre-existing relationship as a patient at St. Jude Children's Research Hospital.

You may qualify if:

  • Diagnosis of sickle cell disease (all genotypes).
  • Age 16.0 - 20.99 years at initial assessment.
  • Primary language is English.

You may not qualify if:

  • Participant unable to complete the questionnaires due to refusal, current acute illness (e.g., pain crisis), or significant cognitive impairment as judged by health care providers at the SCD clinic.
  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Methodist Adult Comprehensive Sickle Cell Center

Memphis, Tennessee, 38104, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jerlym Porter, PhD, MPH

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 13, 2018

Study Start

July 31, 2018

Primary Completion

January 31, 2022

Study Completion

May 26, 2023

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations