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Recruiting NCT05383911

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

No phase Interventional Sickle Cell Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SCD Shared Decision-Making Toolkit for AYAs - including VR, SCD Shared Decision-Making Toolkit for AYAs - without VR.
Who it may be relevant to
Registry conditions: Sickle Cell Disease. Basic parameters: from 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral 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
  • Behavioral 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 measures

  • 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]
Secondary outcome measures (1)
  • Initiation of disease-modifying therapy [Time frame: Within 6 months post-intervention]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Nemours Children's Hospital, Delaware — Wilmington

Identifiers

NCT: NCT05383911 · 348507

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗