Empowering Adolescents and Young Adults With Sickle Cell Disease as Partners in Treatment Decision Making (EMPOWER-AYA)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 15 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a program to help teens and young adults with sickle cell disease make treatment choices with their care team. It compares virtual reality education with print and video materials for patients ages 15–25, their caregivers, and their providers. Researchers will check whether the program is useful, easy to use, and shows early signs of helping.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Patients must be ages 15–25, have sickle cell disease, and get care at Nemours. Their caregivers may also join.
- The patient's sickle cell provider must say they can start at least one treatment that changes the course of the disease.
- Nemours healthcare providers who treat sickle cell disease may also join.
- All participants must be fluent in English.
Who can't join
- Patients and caregivers cannot join if they helped test how easy the program was to use before this study.
- Patients cannot join if they have a history of seizures.
- Patients cannot join if their health or problems with thinking prevent them from completing interviews.
- Patients under 18 cannot join if no legal guardian is available to give permission.
- Providers cannot join if they are still completing their training.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
DE
- Nemours Children's Hospital, Delaware · Wilmington, DE 19803More trials in Wilmington