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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04602780
Registration number
NCT04602780
Ethics application status
Date submitted
20/10/2020
Date registered
26/10/2020
Date last updated
28/10/2020
Titles & IDs
Public title
Evaluating the Revised WORQ in CI Users
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Scientific title
Evaluating the Revised Work Rehabilitation Questionnaire in Cochlear Implant Users
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Secondary ID [1]
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20/23/300
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hearing Loss
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Condition category
Condition code
Ear
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Deafness
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
CI users -
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Completion of the WORQ questionnaire
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Assessment method [1]
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Part 1: Work situation and educational background of participants
School education
Remunerative employment
Part 2: Daily life functioning of participants
Emotional functions
Vestibular functions
Carrying out daily routine
Stress
Conversation
Communication devices and techniques
Tinnitus and dizziness
Community life
Family relationships
Part I addresses demographics and relevant background information. In Part 2, participants have to rate to what extent they had problems with a certain task or activity in the last week based on a numerical scale ranging from 0 (no problem) to 10 (complete problem).
Each individual WORQ item is linked to an ICF qualifier, which is a numerical code that specifies the extent or magnitude of functioning or disability in that ICF category or the extent to which a contextual factor is a facilitator or barrier.
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Timepoint [1]
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One test interval, at least one year after Cochlear Implantation
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Eligibility
Key inclusion criteria
- Adults over the age of 18 years
- Adults must wear a MED-EL cochlear implant
- Adults may have the following hearing indications and device fitting:
- Unilateral cochlear implant with severe-to-profound hearing loss
- Bilateral cochlear implant with severe-to-profound hearing loss
- Single sided deafness (SSD) where the poorer ear PTA =70 dB HL and the better ear
PTA =30 dB HL with an interaural threshold gap of =40 dB HL.
- Asymmetrical hearing loss using a cochlear implant in the poorer ear and a
hearing aid in the better ear (also known as bimodal fitting). The poorer ear PTA
=70 dB HL and the better ear PTA >30 dB HL and =55 dB HL with an interaural
threshold gap of =15 dB HL.
- Adults should have a minimum of one year's device experience
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion Criteria
No extra exclusion criteria
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/09/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/07/2020
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Sample size
Target
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Accrual to date
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Final
177
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Fiona Stanley Fremantle Hospital Group - Perth
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Recruitment postcode(s) [1]
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- Perth
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Edegem
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Country [2]
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Germany
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State/province [2]
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Würzburg
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Country [3]
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Poland
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State/province [3]
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Kajetany
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Country [4]
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Spain
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State/province [4]
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Madrid
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Funding & Sponsors
Primary sponsor type
Other
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Name
University Hospital, Antwerp
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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World Hearing Centre
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Address [1]
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0
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Country [1]
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0
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Other collaborator category [2]
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Other
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Name [2]
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Hospital Universitario La Paz
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Address [2]
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Country [2]
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0
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Other collaborator category [3]
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Other
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Name [3]
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Fiona Stanley Hospital
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Address [3]
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Country [3]
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0
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Other collaborator category [4]
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Other
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Name [4]
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Wuerzburg University Hospital
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Address [4]
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Country [4]
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
The Work Related Questionnaire (WORQ) is a 59-item questionnaire of which each item
represents an International Classification of Functioning and disability category. The WORQ
was modified and reduced to include only questions relevant to Cochlear Implant (CI) users.
In this analysis, a multicentre retrospective review of the revised WORQ in CI users was
performed, with the revised WORQ as part of the questionnaires used in the regular clinical
follow-up of CI users. Experienced CI users' responses on the questions will be evaluated to
define the qualifiers for the revised WORQ.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04602780
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04602780
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