Hearing LossNCT04602780
Evaluating the Revised WORQ in CI Users
An observational study of Hearing Loss, run by University Hospital, Antwerp at 5 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- How many people
- 177 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 4 Sep 2019to 13 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Experienced adult CI users
Who may be able to join
- 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
Who cannot join
- No extra exclusion criteria
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: Evaluating the Revised Work Rehabilitation Questionnaire in Cochlear Implant Users
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.
- Conditions
- Hearing Loss
- Keywords
- Work Rehabilitation Questionnaire, International Classification of Functioning, Disability and Health, Cochlear Implantation
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CI users | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of the WORQ questionnaire
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.
Measured: One test interval, at least one year after Cochlear Implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start4 Sep 2019
- Primary completion13 Jul 2020
- Study completion13 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- World Hearing Centre, Hospital Universitario La Paz, Fiona Stanley Hospital, Wuerzburg University Hospital
- Responsible party
- Principal investigator, Griet Mertens, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602780
- Sponsor's protocol ID
- 20/23/300
- Status last verified
- Oct 2020
- First submitted
- 20 Oct 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Revised Work Rehabilitation Questionnaire in Cochlear Implant Users
- ClinicalTrials.gov ID
- NCT04602780
- Acronym / sponsor ID
- 20/23/300
- Conditions
- Hearing Loss
- Keywords
- Work Rehabilitation Questionnaire, International Classification of Functioning, Disability and Health, Cochlear Implantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- World Hearing Centre, Hospital Universitario La Paz, Fiona Stanley Hospital, Wuerzburg University Hospital
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CI users | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Experienced adult CI users
Key inclusion criteria (8 listed)
- 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:
- Adults should have a minimum of one year's device experience
Key exclusion criteria (1 listed)
- No extra exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Completion of the WORQ questionnaire
Time frame: One test interval, at least one year after Cochlear Implantation
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by University Hospital, Antwerp at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, Belgium, Germany, Poland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of the WORQ questionnaire (time frame: One test interval, at least one year after Cochlear Implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.