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

Not Applicable

Recruiting

• Conditions: Sickle Cell Disease
• Interventions: Behavioral: SCD Shared Decision-Making Toolkit for AYAs - including VR; Behavioral: SCD Shared Decision-Making Toolkit for AYAs - without VR

• Registration Number: NCT05383911
• Lead Sponsor: Nemours Children's Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-17
• Study First Posted: 2022-05-20
• Study Start: 2024-11-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shared Decision Making Toolkit including VR	SCD Shared Decision-Making Toolkit for AYAs - including VR	-
Shared Decision Making Toolkit without VR	SCD Shared Decision-Making Toolkit for AYAs - without VR	-

Primary Outcome Measures

Name	Time	Method
Participant Recruitment Rate	Time of enrollment through study completion, approximately 12 months	Rate of participant enrollment and retention in the study
Disease-Modifying Therapy Knowledge Questionnaire	Within 2 weeks post-intervention	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.
Patient/Caregiver Satisfaction Questionnaire	Within 2 weeks post-intervention	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.
Acceptability of Intervention Measure (AIM)	Within 2 weeks post-intervention	Questionnaire assessing healthcare provider perspectives on acceptability of the intervention. Total score ranges from 4-20, with higher scores indicating greater acceptability.
Feasibility of Intervention Measure (FIM)	Within 2 weeks post-intervention	Questionnaire assessing healthcare provider perspectives on the feasibility of the intervention. Total score ranges from 4-20, with higher scores indicating greater feasibility.
Shared Decision Making Questionnaire (SDM-Q-9)	Within 2 weeks post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
Initiation of disease-modifying therapy	Within 6 months post-intervention	Proportion of patients who agree to initiate a disease-modifying therapy following use of the shared decision making intervention

Trial Locations

Locations (1)

Nemours Children's Hospital, Delaware; 🇺🇸 Wilmington, Delaware, United States