The Mere-measurement Effect of Patient-reported Outcomes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Vienna
About this trial
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?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Strong English skills*
Technology savvy - able to complete online questionnaire
Muscle tension dysphonia
Inducible laryngeal obstruction
Disqualifiers
Under the age of 18
Trial design
Design model
Parallel
Treatments tested in this trial
Patient-reported outcomes for speech disorders: positive
Other interventionThe 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.
Treatment groups
170 Participants
are divided into 3 treatment groupsGroup A: Control: unhealthyNo intervention 0 interventions
Group B: Control: healthyNo intervention 0 interventions
Group C: Experimental groupsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
audio recording of a standardized text
• An audio recording of a standardized text, with the order of the paragraphs randomized in between every exposure. This text was adapted from the standard "Rainbow Passage" read aloud assessment with the field of speech pathologies (Dietsch et al., 2023). Artificial intelligence - ChatGPT - was used to recreate novel text of the same length and difficulty as the "Rainbow Passage" which is called "In the heart of a lush valley" (the text is uploaded in the ECS). An adapted version was opted for to eliminate the possibility of previous exposure.
Time frame
Baseline and at each experimental instance occuring once a week for up to four weeksSecondary outcomes
1
Self-Esteem Stability Scale (SESS)
A three-item self-esteem stability scale - Self-Esteem Stability Scale (SESS). Scores range from 1-6 with higher scores suggesting less stability.
Time frame
Baseline and at each experimental instance occuring once a week for up to four weeks2
Disease activity (1DS)
A single-question measure of disease activity (1DS). Score range of 1-5 with higher scores denoting more activity.
Time frame
Baseline and at each experimental instance occuring once a week for up to four weeks3
A self-esteem scale - Rosenberg Self-Esteem Scale (RSS)
A nine-item scale measuring self-esteem. Score range of 1-4 with high scores denoting lower self-esteem.
Time frame
Baseline and at each experimental instance occuring once a week for up to four weeks4
Disease Impact
Two-question measure of disease impact (2DB). Score range of 1-4 with higher scores denoting more impact.
Time frame
Baseline and at each experimental instance occuring once a week for up to four weeksSponsors and contacts
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Source ClinicalTrials.gov