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

Last updated: November 20, 2025
Sponsor: Nemours Children's Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sickle Cell Disease

Red Blood Cell Disorders

Treatment

SCD Shared Decision-Making Toolkit for AYAs - without VR

SCD Shared Decision-Making Toolkit for AYAs - including VR

Shared Decision Making Intervention

Clinical Study ID

NCT05383911
348507
  • Ages > 15
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with SCD ages 15-25 years receiving treatment at Nemours andtheir caregivers will be included. Patients must be deemed candidates for initiationof one or more disease-modifying therapies by their SCD healthcare provider.

  • Nemours SCD healthcare providers will also be included.

  • English language fluency is a requirement for all participants.

Exclusion

Exclusion Criteria:

  • Patients/ caregivers who previously participated in usability testing of theintervention will be excluded.

  • Patients will also be excluded if they have history of seizures, if their medicalstatus or cognitive functioning preclude completion of interviews, or if no legalguardian is available to provide consent (for patients < 18 years).

  • Providers still completing training will be excluded.

Study Design

Total Participants: 68
Treatment Group(s): 3
Primary Treatment: SCD Shared Decision-Making Toolkit for AYAs - without VR
Phase:
Study Start date:
November 26, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Nemours Children's Hospital, Delaware

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Nemours Children's Hospital, Delaware

    Wilmington 4145381, Delaware 4142224 19803
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.