Helping young people with sickle cell disease make treatment decisions
Official title: Empowering Adolescents and Young Adults With Sickle Cell Disease as Partners in Treatment Decision Making (EMPOWER-AYA)
Run by Nemours Children's Clinic · NCT05383911 · Data updated 2026-11-12
This study is testing a new way to help young people with sickle cell disease and their caregivers make better treatment decisions by using virtual reality alongside regular education materials.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 15 Years and up |
| Sex | All |
| Enrollment | 68 (estimated) |
| Sponsor | Nemours Children's Clinic Academic / other |
| Locations | 1 site (Wilmington, Delaware) |
| Status | Recruiting |
| Started | November 26, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | June 16, 2026 |
| Trial ID | NCT05383911 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adolescents and young adults aged 15-25 with a diagnosis of sickle cell disease who are receiving treatment at Nemours and are eligible for disease-modifying therapies.
✕Probably not a fit
Patients with a history of seizures or those whose medical or cognitive status prevents them from participating in interviews may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates a shared decision-making intervention designed for adolescents and young adults (AYAs) aged 15-25 with sickle cell disease (SCD) and their caregivers. Participants will be recruited from three Nemours Children's Hospitals, where half will receive a virtual reality component alongside standard education materials, while the other half will receive traditional educational resources. The goal is to assess the acceptability, feasibility, and preliminary efficacy of this intervention in empowering AYAs to engage in their treatment decisions. SCD providers will also be trained to utilize decision aids during outpatient visits.
Why it matters
Potential benefit: If successful, this intervention could enhance treatment decision-making and improve health outcomes for young patients with sickle cell disease.
How similar studies have gone: While shared decision-making approaches have been explored in various contexts, this specific intervention combining virtual reality with traditional education is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Nemours Children's Hospital, Delaware
Wilmington, Delaware, United States Recruiting
Study contacts
- Study coordinator: Clinical Research Coordinator
- Email: benjamin.bear@nemours.org
- Phone: 302-723-9331
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.