Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Evaluating the Revised Work Rehabilitation Questionnaire in Cochlear Implant Users
Secondary ID [1] 0 0
20/23/300
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
CI users -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Completion of the WORQ questionnaire
Timepoint [1] 0 0
One test interval, at least one year after Cochlear Implantation

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria

No extra exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/07/2020
Sample size
Target
Accrual to date
Final
177
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Fiona Stanley Fremantle Hospital Group - Perth
Recruitment postcode(s) [1] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Edegem
Country [2] 0 0
Germany
State/province [2] 0 0
Würzburg
Country [3] 0 0
Poland
State/province [3] 0 0
Kajetany
Country [4] 0 0
Spain
State/province [4] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Other
Name
University Hospital, Antwerp
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
World Hearing Centre
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Hospital Universitario La Paz
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Fiona Stanley Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Wuerzburg University Hospital
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04602780
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04602780