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

Sickle Cell Disease Clinical Trial

— EMPOWER-AYA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05383911
• Other study ID #: 348507
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute healthcare utilization	ED visits and hospitalizations for sickle cell-related complications during 6 months following the intervention	Within 6 months post-intervention
Primary	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
Primary	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
Primary	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
Primary	Participant Recruitment Rate	Rate of participant enrollment and retention in the study	Time of enrollment through study completion, approximately 12 months
Primary	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
Primary	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	Initiation of disease-modifying therapy	Proportion of patients who agree to initiate a disease-modifying therapy following use of the shared decision making intervention	Within 6 months post-intervention