Evaluating the Revised WORQ in CI Users

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss

• Study Type: Observational
• Enrollment (Actual): 177

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Experienced adult CI users

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CI users

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Wuerzburg University Hospital; Hospital Universitario La Paz; Fiona Stanley Hospital; World Hearing Centre

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2019
• Primary Completion (Actual): July 13, 2020
• Study Completion (Actual): July 13, 2020

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: International Classification of Functioning, Disability and Health; Cochlear Implantation; Work Rehabilitation Questionnaire
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: 20/23/300

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No