NCT05383911 Empowering Adolescents and Young Adults With Sickle Cell Disease as Partners in Treatment Decision Making (EMPOWER-AYA)
| NCT ID | NCT05383911 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nemours Children's Clinic |
| Condition | Sickle Cell Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2024-11-26 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2024-11-26 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria: * Patients diagnosed with SCD ages 15-25 years receiving treatment at Nemours and their caregivers will be included. Patients must be deemed candidates for initiation of 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 Criteria: * Patients/ caregivers who previously participated in usability testing of the intervention will be excluded. * Patients will also be excluded if they have history of seizures, if their medical status or cognitive functioning preclude completion of interviews, or if no legal guardian is available to provide consent (for patients \< 18 years). * Providers still completing training will be excluded.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05383911 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying Sickle Cell Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05383911 currently recruiting?
Yes, NCT05383911 is actively recruiting participants. Contact the research team at benjamin.bear@nemours.org for enrollment information.
Where is the NCT05383911 trial being conducted?
This trial is being conducted at Wilmington, United States.
Who is sponsoring the NCT05383911 clinical trial?
NCT05383911 is sponsored by Nemours Children's Clinic. The trial plans to enroll 68 participants.
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