Evaluating the Revised WORQ in CI Users

Completed

• Conditions: Hearing Loss

• Registration Number: NCT04602780
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-04
• Primary Completion: 2020-07-13
• Study Completion: 2020-07-13
• Status Verified: 2020-10
• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-26
• Last Update Submitted: 2020-10-26
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Completion of the WORQ questionnaire	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.

Trial Locations

Locations (5)

World Hearing Centre; 🇵🇱 Kajetany, Poland

University Hospital Antwerp; 🇧🇪 Edegem, Belgium

University Clinic of Würzburg; 🇩🇪 Würzburg, Germany

Fiona Stanley Fremantle Hospital Group; 🇦🇺 Perth, Australia

Hospital La Paz; 🇪🇸 Madrid, Spain