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The Mere-measurement Effect of Patient-reported Outcomes

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Final enrollment: 128 participants (planned 170) · Primary completion date changed from estimate of Sep 22, 2025 to Apr 22, 2025 · Study completion date changed from estimate of Dec 22, 2025 to Apr 20, 2026 · 5 more Show 8 more changesShow less
    • Final enrollment: 128 participants (planned 170)
    • Primary completion date changed from estimate of Sep 22, 2025 to Apr 22, 2025
    • Study completion date changed from estimate of Dec 22, 2025 to Apr 20, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description expanded, about 26 words
    • Site details revised
    • Publications: details revised at 10 of 10 entries
  2. Primary completion date: Feb 22, 2025 to Sep 22, 2025 Completion date: May 22, 2025 to Dec 22, 2025v3 Show 1 more changeShow less
    • Completion date: May 22, 2025 to Dec 22, 2025
  3. Primary completion date: Aug 22, 2024 to Feb 22, 2025v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 use of patient-reported outcome (PROs) have become increasingly commonplace across many healthcare settings over the past two decades. The value of PROs is now acknowledged by healthcare providers and patients alike. However, to date, little is known about the best practices for formulating PRO measures (PROMS), but even more specifically, the effect had on the responding patients as a result of item word choice, emotional valence, or frequency of use. That is, 1) does the positive or negative wording of items affect the patient's perspective on the latent variable, 2) is there a degree of subliminal influence or measurement effects on their behaviour resulting from exposure to PROs, and finally, 3) is such an effect amplified with repeated exposure?
Trial Details
NCT Number NCT06443073
Lead Sponsor Medical University of Vienna
Conditions Measurement, Psychological Stress, Speech Disorders, Assessment, Self
Enrollment 128 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov