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RECRUITING NA

Empowering Adolescents and Young Adults With Sickle Cell Disease as Partners in Treatment Decision Making (EMPOWER-AYA)

NCT05383911 · View on ClinicalTrials.gov ↗

Study Summary

This study will evaluate the acceptability, feasibility, and preliminary efficacy of a shared decision making intervention for adolescents and young adults (AYAs) with sickle cell disease (SCD). 60 AYAs with SCD ages 15-25 and their caregivers and 8 SCD providers will participate in the pilot pragmatic trial. AYAs, caregivers, and providers will be recruited from Nemours Children's Hospital, Delaware (NCH-DE), Nemours Children's Hospital in Orlando, FL (NCH-ORL), and Nemours Children's Health at Wolfson Children's Hospital in Jacksonville, FL (NCH-JAX). NCH-DE participants (n=30) will receive the SDM intervention including a virtual reality patient health education component, whereas NCH-ORL and NCH-JAX participants (n=30) will receive the SDM intervention with standard patient education materials (print, video). SCD providers will be trained to use the toolkit components and will introduce decision aids during an outpatient clinic visit for AYAs who are candidates for one or more disease-modifying therapies.

Conditions Studied

Interventions

  • BEHAVIORAL SCD Shared Decision-Making Toolkit for AYAs - including VR
  • BEHAVIORAL SCD Shared Decision-Making Toolkit for AYAs - without VR

Study Locations (1)

Delaware

  • Nemours Children's Hospital, Delaware — Wilmington

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2024-11-26
Est. Completion 2026-12-31
Phase NA

Sponsor

Nemours Children's Clinic

96 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05383911

The ClinicalTrials.gov registry entry for NCT05383911 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nemours Children's Clinic, which has 96 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions — of which SCD Shared Decision-Making Toolkit for AYAs - including VR is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05383911 reports 1 study location spanning 1 distinct geographic area — top geographies include Delaware. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05383911 about?

NCT05383911 is a clinical study titled "Empowering Adolescents and Young Adults With Sickle Cell Disease as Partners in Treatment Decision Making (EMPOWER-AYA)". This study will evaluate the acceptability, feasibility, and preliminary efficacy of a shared decision making intervention for adolescents and young adults (AYAs) with sickle cell disease (SCD). 60 AYAs with SCD ages 15-25 and their caregivers and 8 SCD providers will participate in the pilot pragma...

What is the current status of trial NCT05383911?

This trial is currently recruiting. It is a NA study. The enrollment target is 68 participants. The study started on 2024-11-26. Estimated completion is 2026-12-31.

What conditions does trial NCT05383911 study?

This clinical trial studies the following conditions: Sickle Cell Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05383911?

The interventions under investigation include: SCD Shared Decision-Making Toolkit for AYAs - including VR (BEHAVIORAL), SCD Shared Decision-Making Toolkit for AYAs - without VR (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05383911?

This trial is sponsored by Nemours Children's Clinic, which has 96 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05383911 being conducted?

This trial has 1 study location across Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial