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

Recruiting · NCT05383911 · Interventional (participants receive a specific treatment) · Lead sponsor: Nemours Children's Clinic

View the official record on ClinicalTrials.gov →

Sickle Cell Disease

Interventions studied

SCD Shared Decision-Making Toolkit for AYAs - including VRSCD Shared Decision-Making Toolkit for AYAs - without VR

What this trial is about

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.

Who can take part

Age range

15 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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 is running

1 location listed across 1 US state.

Nemours Children's Hospital, Delaware - Wilmington, Delaware, United States

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →