Evaluating the Revised WORQ in CI Users

NCT04602780 | Completed

• 1 other identifier: 20/23/300
• Study Type: observational
• Target: 177
• Locations: 5 countries
• Sites: 5

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.

Conditions

Hearing Loss

Keywords

Work Rehabilitation Questionnaire; International Classification of Functioning, Disability and Health; Cochlear Implantation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

CI users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Experienced adult CI users

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• World Hearing Centre: collaborator
• Hospital Universitario La Paz: collaborator
• Fiona Stanley Hospital: collaborator
• Wuerzburg University Hospital: collaborator

Study Sites (5)

Fiona Stanley Fremantle Hospital Group

Perth, Australia

Location

University Hospital Antwerp

Edegem, Belgium

Location

University Clinic of Würzburg

Würzburg, Germany

Location

World Hearing Centre

Kajetany, Poland

Location

Hospital La Paz

Madrid, Spain

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: September 4, 2019
• Primary Completion: July 13, 2020
• Study Completion: July 13, 2020
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

PL (1); DE (1); BE (1); AU (1); ES (1)