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The "What Is Important to Us" Communication Intervention Pilot Clinical Trial

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Notable Phase: Phase 1/2 to Phase 2v3 Show 10 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 100 to 160
    • Start date changed from estimate of Jul 1, 2024 to Feb 10, 2025
    • Study sites: 0 to 1
    • Study completion date: May 30, 2027 to May 15, 2027
    • Interventions: Photo-Narrative (Behavioral) to "What Is Important to Us" Communication Intervention (Behavioral)
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints expanded, about 38 words
    • Study description expanded, about 120 words
    • Study title expanded, about 9 words
  2. Minor Eligibility criteria shortened, about 17 words
    • Study title shortened, about 3 words
    v2
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The objective of this study is to conduct a pilot randomized controlled trial (RCT) of a photo-narrative communication intervention developed by our study team with patients/parents of children with severe neurological impairment (SNI) and their pediatric intensive care unit (PICU) clinicians to assess feasibility, acceptability, and early efficacy.
Trial Details
NCT Number NCT06208332
Lead Sponsor Seattle Children's Hospital
Conditions
(from sponsor)
Critical Illness, Neurologic Disorder
Related terms Communication, Critical Illness, Nervous System Diseases, Neurologic Manifestations
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov