Clinical trial NCT05383911: Empowering Adolescents and Young Adults With Sickle Cell Disease as Partners in Treatment Decision Making (EMPOWER-AYA)
Official title: Empowering Adolescents and Young Adults With Sickle Cell Disease as Partners in Treatment Decision Making (EMPOWER-AYA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sickle Cell Disease
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 68
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Within 2 weeks post-intervention
measure: Patient/Caregiver Satisfaction Questionnaire
timeFrame: Within 2 weeks post-intervention
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Within 2 weeks post-intervention
measure: Participant Recruitment Rate
timeFrame: Time of enrollment through study completion, approximately 12 months
measure: Shared Decision Making Questionnaire (SDM-Q-9)
timeFrame: Within 2 weeks post-intervention
measure: Disease-Modifying Therapy Knowledge Questionnaire
timeFrame: Within 2 weeks post-intervention
Secondary outcomes:
measure: Initiation of disease-modifying therapy
timeFrame: Within 6 months post-intervention
Other outcomes:
measure: Acute healthcare utilization
timeFrame: Within 6 months post-intervention
Locations:
city: Wilmington
country: United States
facility: Nemours Children's Hospital, Delaware
state: Delaware
Study officials:
References: