Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05383911 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: EMPOWER-AYA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 30, 2026 to Dec 31, 2026
    • Study completion pushed from Dec 31, 2026 to Jun 30, 2027
    v17
  2. Re-verified, no change to tracked fieldsv16
  3. Primary completion date: Nov 30, 2025 to Jun 30, 2026
    • Study completion date: Nov 30, 2025 to Dec 31, 2026
    v15
  4. Primary and study completion dates: Jun 30, 2025 to Nov 30, 2025v14
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 30, 2024 to Nov 26, 2024
    v13
Show 11 earlier versionsHide 11 earlier versions
  1. Start date: Oct 30, 2024 to Nov 30, 2024v12
  2. Start date: Sep 30, 2024 to Oct 30, 2024v11
  3. Start date: Aug 2024 to Sep 30, 2024
    • Primary and study completion dates: Jun 2025 to Jun 30, 2025
    v10
  4. Start date: Jun 2024 to Aug 2024v9
  5. Re-verified, no change to tracked fieldsv8
  6. Interventions: Shared Decision Making Intervention (Behavioral) to SCD Shared Decision-Making Toolkit for AYAs - including VR (Behavioral), SCD Shared Decision-Making Toolkit for AYAs - without VR…v7
  7. Enrollment target: 40 to 68
    • Primary and study completion dates: Dec 2024 to Jun 2025
    • Study arms: 1 to 2
    • Eligibility criteria expanded, about 2 words
    v6
  8. Start date: Feb 2024 to Jun 2024
    • Primary and study completion dates: Jun 2024 to Dec 2024
    v5
  9. Start date: Sep 2023 to Feb 2024v4
  10. Re-verified, no change to tracked fieldsv3
  11. Primary completion date: May 2024 to Jun 2024
    • Start date: Aug 2023 to Sep 2023
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05383911
Lead Sponsor Nemours Children's Clinic
Conditions
(from sponsor)		 Sickle Cell Disease
Related terms Anemia, Sickle Cell
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov