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Completed

NCT Number: NCT04602780

Evaluating the Revised WORQ in CI 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fiona Stanley Fremantle Hospital Group, Perth, Australia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Fiona Stanley Hospital
  • Hospital Universitario La Paz
  • World Hearing Centre
  • Wuerzburg University Hospital

Registry information

Official study title

Evaluating the Revised Work Rehabilitation Questionnaire in Cochlear Implant Users

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 26, 2020
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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