Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06443073 |
| Other study ID # |
ECS 2153/2023 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2024 |
| Est. completion date |
May 22, 2025 |
Study information
| Verified date |
June 2024 |
| Source |
Medical University of Vienna |
| Contact |
Preston Long, PhD |
| Phone |
+43 (0)1 40400-66100 |
| Email |
preston.long[@]meduniwien.ac.at |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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?
Description:
There is currently sufficient evidence to suggest that attributes such as the wording of
questions, their presentation order, the context where they are asked, and the item's social
sensitivity (e.g. I do not abuse my prescriptions), have an effect on participant responses
(1,2). This family of variables are most oft referred to as method effects. Method effects
largely regard the phenomenon in which the presentation of an item affects the participant's
response independent of the content in question. The end goal within this area of study is to
correct for any response bias resulting from the items used. This research primarily concerns
psychometrics. It is important to note that while method effects relate to the research
questions proposed, it is not the key feature of interest. The ensuing inquiry will not
simply focus directly on changes to item responses, but instead, on changes to patient
perceptions and behaviours as a result of their exposure to the measures themselves. This has
been coined the mere-measurement effect (3) Research supports the claim that asking certain
questions can influence behaviours on the same topic (4,5). For example, a randomized-control
trial was conducted to assess the impact of asking questions pertaining to blood donation
habits of the participants. The researchers found that the subjects whom were asked about
their habits were significantly more likely to donate blood than their control counter parts
at the following blood-drive (6). Other researchers found that when clinicians did not ask
patients with Attention Deficit Hyperactivity Disorder (ADHD) to report whether they were
currently medicated on a disease-related severity questionnaire, patients were more likely to
report un-medicated symptomologies (7). In other words, patients on ADHD medications
responded more symptomatically similar to their un-medicated selves when their medication
status was not included on the questionnaire. This suggests that the medication status item
itself, may have mitigated ADHD symptoms by bringing the patient's treatment into a higher
state of awareness/directing attention.
Thus, it may be that asking patients about their intent to have an operation increases the
likelihood of them opting for it, or, that asking them about their exercise increases their
physical activity level. If so, this may have significant implications for the effect of
routinely collecting patient-reported outcomes (PROs), as well as for utilizing measurements
as interventions. However, before value can be attached to such an effect, first the presence
and strength must be evaluated in the patient-specific context.
To date, no mere-measurement effect factors have been investigated in the context of
patient-reported outcomes measures (PROMs) and particularly not in regard to how they may
influence patient perceptions and behaviours. Therefore, exploration of this family of
effects must be reduced to a few key anticipated features, namely, emotional valence
(positive/negative) and frequency. For instance, would wording a cleft-lip question
negatively, such as "I do not like my face", actually decrease the patient's preference for
their own face, and, does repeated exposure to this question increase the magnitude of the
effect.
This randomized controlled trial (RCT) review will be the first to the authors' knowledge to
examine if measuring patient- reported outcomes directly effects their corresponding
behaviour, and if this effect can be attributed in part to item wording and/or frequency of
exposure.
PROMs & Speech Disorders Three recent reviews regarding patient-reported outcomes in speech
pathologies were identified (8,9,10). Francis et al. list a number of PRO measures that were
designed for administration with subjects with any kind of voice disorders. The Evaluating
Voice Disability-Quality of Life Questionaire (EVD-QOL) aims at assessing the general range
of functional problems in voice disorders. The 30-items Voice Handicap Index (VHI) and its
10-items short version VHI-10 aim at providing a psychometrically robust voice
diasability/handicap inventory. The Voice-Related Quality of Life (V-RQOL) aims at measuring
the impact of voice problems on the quality of life. The Voice Activity and Participation
Profile (VAPP) aims at identifying voice activity limitation and participation restriction
separately. The Voice Symptom Scale (VoiSS) is an inventory of voice symptoms for assessing
baseline pathology and response to change. The Communicative Participation Item Bank (CPIB)
aims at assessing 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.
Additional PROs include the Aging Voice Index, the Evaluation of the Ability to Sing Easily,
the Glottal Function Index, the Linear Analog Scale of Assessment of Voice Quality, the
Speech Disability Questionnaire, the Trans Woman Voice Questionnaire, the Vocal Cord
Dysfunction Questionnaire, and the Vocal Tract Discomfort Scale Slavych, Zraick & Ruleman,
2021.
The researchers have opted to use the CPIB and the VHI because these are well established and
the former covers all kinds of communication disorders, while the VHI is using particularly
negative wording in its original form.
1.2 STUDY RATIONALE The purpose of the mere-measurement study is to identify the most
advantageous way to measure outcomes for patients. This will be accomplished by collecting
measures on the same topic at different time intervals and with different wording of
questions. The findings of this study should help researchers and clinicians collect
measurements from patients in the least burdensome and most beneficial manner possible.
The primary objective of the mere-measurement study is to assess the effects of different
collection methods on the responders wellbeing.
The secondary objectives of this study are to:
- What frequency of collection is best for patients?
- What style of question wording is best for patients?
Research Questions:
- Does the assigned positivity or negativity of an item effect patient perception or
behaviour on the topic inquired?
- Does frequency of exposure to an item have an effect on patient perception or behaviour
of the topic inquired?
Hypotheses:
H1 = The more a patient reads and responds to questions about their speech condition the more
their speech condition will be affected.
H2 = The directionality of impact on a speech condition will be congruent with the emotional
valence of the items used.
STUDY DESIGN Once a subject has agreed to participate in this study, they will be asked to
complete online questionnaires as well as record their voice reading a collection of random
words 2-4 times.
This study follows a 2x2 design. Participants will be randomly assigned to one of four
groups. Randomization will be accomplished by using the MUW randomizer. Participants will be
stratified by education and speech disorder type. The healthy case control group will undergo
case matching to ensure comparability across groups. Each group will receive two brief speech
pathology severity questionnaires but at different frequencies, and with slight adjustments
to the wording. Depending on the experimental group, a subject will complete the
questionnaires either two or four times, separated each time by one week. The questionnaires,
in all groups, will take approximately 15 minutes to complete. Lastly, at the very start and
once at the very end of the study, every participant will also be asked to record a brief 45
second audio file in the online survey as well as complete two additional psychological
questionnaires.
The measures in this study cover the following tools (complete measures are uploaded in the
ECS):
- A patient-reported outcome on voice health - Voice Handicap Index (VHI) or Voice
Handicap Index Positively adapted (VHI-PA)
- A patient-reported outcome on speech health - Communicative Participation Item Bank
(CPIB) or Communicative Participation Item Bank Positively adapted (CPIB-PA)
- A self-esteem stability scale - Self-Esteem Stability Scale (SESS)
- A self-esteem scale - Rosenberg Self-Esteem Scale (RSS)
- Two question measure of disease impact (2DB)
- A single-question measure of disease activity (1DS)
- Audio recording of text read aloud (ARec)
Study population All patients with Muscle tension dysphonia, Inducible laryngeal obstruction,
Amyotrophic lateral sclerosis (ALS), suffering from a stroke or other brain
injury/damage/trauma, (aphasia, dysarthria), and Parkinson's disease will be targeted for
recruitment. There are no geographic location requirements. The participation schedule can be
found below. Patients will be informed of the schedule in advance. A subject must complete
any respective sampling epoch within 48 hours of the prescribed date in order to qualify as
completed. Subjects must also have strong English skills and be technologically savvy to
participate. Only adults will be included in the study.
Study Design Flow Group 1: High frequency-negative: 1 week between each collection
1. Demographics, VHI, CPIB, SESS, RSS, 1DS, 1DB, ARec*
2. VHI, CPIB, SE, SSE, 1DS, 2DB, ARec
3. VHI, CPIB, SE, SSE, 1DS, 2DB, ARec
4. VHI, CPIB, SE, SSE, 1DS, 2DB, ARec Group 2: High frequency-positive: 1 week between each
collection
1. Demographics, VHI-PA, CPIB-PA, SESS, RSS, 1DS, 2DB, ARec*
2. VHI-PA, CPIB-PA, SE, SSE, 1DS, 2DB, ARec
3. VHI-PA, CPIB-PA, SE, SSE, 1DS, 2DB, ARec
4. VHI-PA, CPIB-PA, SE, SSE, 1DS, 2DB, ARec Group 3: Low frequency-negative: 2 weeks
between each collection
1: Demographics, VHI, CPIB, SESS, RSS, 1DS, 2DB, ARec* 2: VHI, CPIB, SE, SSE, 1DS, 2DB, ARec
Group 4: Low frequency-positive: 2 weeks between each collection
1. Demographics, VHI-PA, CPIB-PA, SESS, RSS, 1DS, 2DB, 1ARec*
2. VHI-PA, CPIB-PA, SE, SSE, 1DS, 2DB, 1ARec Control: (once at start, once at low frequency
completion/final outcome collection, once at high frequency completion)
1: Demographics, ARec x 3
Healthy Control: (once at start, once at low frequency completion/ final outcome collection,
once at high frequency completion)
1. Demographics, ARec x 3
*completed prior to assessments
*English was chosen as the study language as a wider range of validated assessments
exist in this language. The AI used for speech analysis is also best suited for and
trained (66%) on English. Lastly, English is the most prolific language (native +
secondary speakers) in the world which will facilitate the speed of recruitment.
Subjects who meet any of the following criteria will be excluded from study entry:
• Under the age of 18
NUMBER OF SUBJECTS PARTICIPATING IN THE STUDY Subjects will be randomly separated into
six groups including control and healthy control, with approximately 33 subjects per
group. A formal power analysis was performed using G*power with parameters sourced from
relevant seminal research (Conner et al., 2011; Godin et al., 2011). The following
parameters were used for the sample size analysis: two-tailed directionality; effect
size of 0.30; a priori computation, anticipated power of 0.95, and an error rate of
0.0023. Means difference tests between independent groups within the t-test family were
utilized.
RECRUITMENT PROCEDURE Recruitment into the mere-measurement study will be performed
supported by Probando. Probando is a previously approved patient recruitment service
that specializes in online advertising. All recruitment materials are uploaded to the
ECS. A description of the Probando recruitment service and procedures can be found as an
attachment, as well as the recruitment materials for all subjects including healthy
controls and a screenshot of the currently inactive landing page. As a part of their
service, Probando uses the study inclusion and exclusion criteria to screen potential
interested subjects. If they qualify and permit contact, their contact information will
be provided to the MUW researchers for direct outreach. Therefore, all study timings,
measures, and data will be distributed and collected only by the study researchers.
Patients will be able to withdraw from the study at any time without providing a reason.
To limit potential bias, an initial self-report of an official diagnosis is required to
participate. Additionally, the patients will also confirm their diagnosis with a
checkbox, for the purpose of minimizing the risk of malingering patients. If an
individual is highly motivated to participate and does not suffer from a qualifying
speech disorder they can still apply to participate as a healthy control. Furthermore,
this sample would be more representative of a telemedicine community.
DATA SOURCES
Participants' and study data will be recorded in the study database. Study data will be
collected at defined time points (see Section 1.5) using a single online format:
• SoSci survey (www.soscisurvey.de) is a routinely used, safe, online questionnaire
distribution and data retrieval platform. Within this platform, five links will be
created, one for each group. These will connect subjects to the questionnaires and to
the instructions for capturing the audio file.
An email address for every participant will be required for communication and
dissemination of participation credits. All individuals with access to participants'
personal information are obligated to respect their privacy and only use and disclose
their information as described in the informed consent document.
Demographic information and mere-measurement study results are secured against
unauthorized access. Security measures reduce the risk of unauthorized individuals
accessing subject personal information, but such risks cannot be entirely eliminated.
All audio recordings will be stored only for the duration of the study. Upon closure,
they will be deleted.
The information collected from the mere-measurement study will be kept confidential.
Subject personal information will be stored safely at MUW and pseudonymized as discussed
in the previous section.
DATA COLLECTION
Online, subjects will complete a battery of questionnaires totalling approximately 15-20
minutes of time following the informed consent. Informed consent will be collected
online via the SoSci survey tool. The following parameters will be applied to the
virtual informed consent:
• The patient information including the data protection section is displayed above the
checkbox. The patients are informed about what happens to their data, their benefits,
and risks in sufficient detail but simple detail in this section.
• The checkbox says that patients have read and understood the text and that they agree.
• The patients will confirm their diagnosis with a checkbox, for the purpose of
minimizing the risk of malingering patients Depending on the group assigned, a
participant will have to complete this battery either 2 or 4 times. The control and
healthy group will complete only demographics questions and the audio recordings, no
PROMs will be collected. The four intervention groups will be randomized using a digital
randomization tool provided by the MUW (https://www.meduniwien.ac.at/randomizer/ ).
All patients, across all intervention groups, will complete the read-aloud activity
prior to the first collection of PROMs. This will serve as the baseline for later
comparison. Following the first recording, all subsequent recordings will be completed
after completing the PROMs. An electronic bank transfer form (MUW standard bank form)
will be emailed to participants at the end of the study to complete the 50€ transfer.
These electronic records will be immediately destroyed upon successful completion.
DATA MANAGEMENT Patient-reported data will be captured using SoSci survey with an
account owned by the Center for Outcomes Research. These data will not be transferred
outside of the MUW. Data transfers between the investigators of this study will be
managed using procedures described in a jointly developed Data Transfer Plan. All data
transferred between the two MUW centers, speech pathology and outcome research, will be
identified only by a subject ID code, unless otherwise consented by patients and agreed
upon in the Data Transfer Plan.
DATA QUALITY ASSURANCE Patients will consent that pseudonymized patient data will be
hosted and analysed at the MUW. MUW will not share the data with any third parties or
collaborators. MUW regularly processes medical data and is subject to the GDPR
requirements. MUW is responsible for data quality and will perform oversight of the data
management of this study. Investigators and study coordinators will receive an initial
training session on the protocol, study flow, study database, survey tool,
documentation, and expectations, and any applicable study processes. Access to data for
secondary use cases will not be enabled.
SOURCE DATA DOCUMENTATION
Source documents (electronic) are those in which participant data are recorded and
documented for the first time. The source documentation for this study will be:
- Participant demographic information and eligibility assessment
- Completed Informed Consent Forms
- Audio recordings
- Completed PROMs
