Evaluating Simplified Layered Consent for Clinical Trials

Study acronym: SIMPLY-SNAP
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed Show 8 more changesShow less
    • Primary completion date changed from estimate of Jun 2026 to Apr 16, 2026
    • Enrollment target: estimated 346 to confirmed 347
    • Study completion date changed from estimate of Jun 2026 to Apr 19, 2026
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Site details revised at 6 of 6 sites
    • Collaborators: details revised at 1 of 1 entry
    • Publications: details revised at 1 of 1 entry
  2. Primary and study completion dates: Jun 2025 to Jun 2026
    • Study sites: 8 to 6
    v2
  3. Study First Submitted
  • 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 goal of this clinical trial (the SIMPLY-SNAP trial) is to compare a simplified layered consent form to a full-length consent form for use during the informed consent process for a larger clinical trial of treatment of Staphylococcus aureus bloodstream infection (the SNAP trial). The main questions it aims to answer are: * Does use of a simplified layered consent form lead to an increased recruitment rate to the SNAP trial? * Does use of a simplified layer consent form lead to increased participant understanding of the SNAP trial and increased participant satisfaction with the informed consent process? Participants will be randomized to either the full-length informed consent form or the simplified layered consent form containing links to optional supplementary information or videos. Research staff will use the assigned form to explain the SNAP trial to participants. After consent, participants will be evaluated on their understanding of the SNAP trial and satisfaction with the consent process using a questionnaire.
Trial Details
NCT Number NCT06168474
Lead Sponsor Sunnybrook Health Sciences Centre
Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions
(from sponsor)		 Staphylococcus Aureus Bacteremia
Enrollment 347 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov