Evaluating the Revised WORQ in CI Users

Hearing Loss Clinical Trial

Official title:

Evaluating the Revised Work Rehabilitation Questionnaire in Cochlear Implant Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602780
• Other study ID #: 20/23/300
• Status: Completed
• Start date: September 4, 2019
• Est. completion date: July 13, 2020

Study information

• Verified date: October 2020
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: July 13, 2020
• Est. primary completion date: July 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria

No extra exclusion criteria

Related Conditions & MeSH terms

• Hearing Loss

Locations

Country	Name	City	State
Australia	Fiona Stanley Fremantle Hospital Group	Perth
Belgium	University Hospital Antwerp	Edegem
Germany	University Clinic of Würzburg	Würzburg
Poland	World Hearing Centre	Kajetany
Spain	Hospital La Paz	Madrid

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Fiona Stanley Hospital, Hospital Universitario La Paz, World Hearing Centre, Wuerzburg University Hospital

Countries where clinical trial is conducted

Australia,  Belgium,  Germany,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One test interval, at least one year after Cochlear Implantation