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

NCT05383911 | Recruiting

• 1 other identifier: 348507
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Acceptability of Intervention Measure (AIM)

  Questionnaire assessing healthcare provider perspectives on acceptability of the intervention. Total score ranges from 4-20, with higher scores indicating greater acceptability.

  Within 2 weeks post-intervention

• Patient/Caregiver Satisfaction Questionnaire

  Survey assessing patient/caregiver satisfaction with the intervention. Survey will be developed by the research team, and additional details will be included here once items and scoring are finalized.

  Within 2 weeks post-intervention

• Feasibility of Intervention Measure (FIM)

  Questionnaire assessing healthcare provider perspectives on the feasibility of the intervention. Total score ranges from 4-20, with higher scores indicating greater feasibility.

  Within 2 weeks post-intervention

• Participant Recruitment Rate

  Rate of participant enrollment and retention in the study

  Time of enrollment through study completion, approximately 12 months

• Shared Decision Making Questionnaire (SDM-Q-9)

  Questionnaire assessing patient- and caregiver-reported engagement in decision making. Total score ranges from 0 to 100, with higher scores indicating greater engagement in decision making.

  Within 2 weeks post-intervention

• Disease-Modifying Therapy Knowledge Questionnaire

  Questionnaire assessing patient and caregiver knowledge of disease modifying-therapies for sickle cell disease. Survey will be developed by the research team, and additional details will be included here once items and scoring are finalized.

  Within 2 weeks post-intervention

Secondary Outcomes (1)

• Initiation of disease-modifying therapy

  Within 6 months post-intervention

Other Outcomes (1)

• Acute healthcare utilization

  Within 6 months post-intervention

Study Arms (2)

Shared Decision Making Toolkit including VR

EXPERIMENTAL

Behavioral: SCD Shared Decision-Making Toolkit for AYAs - including VR

Shared Decision Making Toolkit without VR

EXPERIMENTAL

Behavioral: SCD Shared Decision-Making Toolkit for AYAs - without VR

Interventions

SCD Shared Decision-Making Toolkit for AYAs - including VR BEHAVIORAL

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).

Shared Decision Making Toolkit including VR

SCD Shared Decision-Making Toolkit for AYAs - without VR BEHAVIORAL

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).

Shared Decision Making Toolkit without VR

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Children's Hospital, Delaware

Wilmington, Delaware, 19803, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Clinical Research Coordinator

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 20, 2022
• Study Start: November 26, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (1)