Helping young people with sickle cell disease make treatment decisions
Empowering Adolescents and Young Adults With Sickle Cell Disease as Partners in Treatment Decision Making (EMPOWER-AYA)
NA · Nemours Children's Clinic · NCT05383911
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Nemours Children's Clinic (other) |
| Locations | 1 site (Wilmington, Delaware) |
| Trial ID | NCT05383911 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While shared decision-making approaches have been explored in various contexts, this specific intervention combining virtual reality with traditional education is relatively novel.
Eligibility criteria
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 this trial is running
Wilmington, Delaware
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sickle Cell Disease