Recruiting

Empower-AYA

Sponsor:

Nemours Children's Clinic

Code:

NCT05383911

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Interventions

SCD Shared Decision-Making Toolkit for AYAs - including VR

SCD Shared Decision-Making Toolkit for AYAs - without VR

Study Details

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.

Conditions

Sickle Cell Disease

Study ID

NCT05383911

Start date

Nov 26, 2024

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

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 Design

Enrollment

68 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Shared Decision Making Toolkit including VR

experimental: Shared Decision Making Toolkit without VR

Interventions

SCD Shared Decision-Making Toolkit for AYAs - including VR

The SCD Shared Decision-Making Toolkit for AYAs (SDMT-AYA) targets multi-level barriers to uptake of disease-modifying therapies by providing technology-enhanced tools for: 1) clinicians (i.e., training in motivational interviewing, values elicitation, and cultural humility); 2) AYAs and caregivers (i.e., user-centered multimedia decision aids, including virtual reality, online (videos, animations, articles), and print materials); and 3) implementation (e.g., clinic audit and feedback strategies).

SCD Shared Decision-Making Toolkit for AYAs - without VR

The SCD Shared Decision-Making Toolkit for AYAs (SDMT-AYA) targets multi-level barriers to uptake of disease-modifying therapies by providing technology-enhanced tools for: 1) clinicians (i.e., training in motivational interviewing, values elicitation, and cultural humility); 2) AYAs and caregivers (i.e., user-centered multimedia decision aids, including online videos, animations, and articles as well as print materials); and 3) implementation (e.g., clinic audit and feedback strategies).

Primary outcome measure

  • Acceptability of Intervention Measure (AIM) [ Time Frame: Within 2 weeks post-intervention ]
  • Patient/Caregiver Satisfaction Questionnaire [ Time Frame: Within 2 weeks post-intervention ]
  • Feasibility of Intervention Measure (FIM) [ Time Frame: Within 2 weeks post-intervention ]
  • Participant Recruitment Rate [ Time Frame: Time of enrollment through study completion, approximately 12 months ]
  • Shared Decision Making Questionnaire (SDM-Q-9) [ Time Frame: Within 2 weeks post-intervention ]
  • Disease-Modifying Therapy Knowledge Questionnaire [ Time Frame: Within 2 weeks post-intervention ]

Central Contacts and Locations

Central contacts

Clinical Research Coordinator

302-723-9331benjamin.bear@nemours.org

Locations

Nemours Children's Hospital, Delaware

Recruiting

Wilmington, Delaware, United States, 19803

More Information

Sponsor

Nemours Children's Clinic

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nemours Children's Clinic on 2026-06-16.