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The Mere-measurement Effect of Patient-reported Outcomes

NCT06443073 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-05-14

No results posted yet for this study

Summary

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?

Conditions

  • Measurement, Psychological Stress
  • Speech Disorders
  • Assessment, Self

Interventions

OTHER

Patient-reported outcomes for speech disorders: positive

The Communicative Participation Item Bank (CPIB) aims to assess communication participation in all kinds of communication disorders. The Voice Self-Efficacy Questionnaire (VSEQ) monitors self-efficacy in individuals with self-declared voice problems before and after interventions. The Vocal Fatigue Handicap Questionnaire (VFHQ) and the Vocal Fatigue Index (VFI) aim at reflecting vocal fatigue. Both have been adapted to reflect purely positive wording.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-09-22
Completion
2025-12-22

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06443073 on ClinicalTrials.gov