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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04942327
Other study ID # Awareness
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 18, 2021
Est. completion date April 30, 2023

Study information

Verified date May 2021
Source Universitair Ziekenhuis Brussel
Contact Sara Tryhou, Bachelor
Phone +32474105120
Email sara.tryhou@uzbrussel.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The following research questions will be investigated: What is the knowledge of medical interventions for moderate to severe hearing loss and what is the knowledge of the reimbursement criteria for hearing implants of otorhinolaryngologists in a secondary setting in Brabant. This will be evaluated by means of a specific questionnaire that will be systematically gone over with the participants during an interview in the first and third phase. In a second phase, the investigators will investigate how the knowledge of medical interventions for moderate to severe hearing loss and the knowledge of the reimbursement criteria for hearing implants of otorhinolaryngologists in a secondary setting in Brabant can be increased by training the otorhinolaryngologists in a secondary setting in Brabant. In the third phase, the investigators will evaluate the knowledge of hearing implant interventions and reimbursement criteria among otorhinolaryngologists in a secondary setting.


Description:

In most developed economies, cochlear implants have been shown to be the most successful neuroprostheses for sensory moderate or severe neurosensory loss. These neuroprostheses are cost-effective with low complication rates. However, the literature indicates that there is a low level of awareness of the benefits of cochlear implants among the general population and among healthcare professionals. In addition, a lack of specific referral pathways has been reported. Utilization rates for adult hearing aids in people with severe or profound loss are 70% to 90%, but uptake in adults for cochlear implants is less than 10%. Therefore, the aim of this research project is to investigate the knowledge about medical interventions in moderate to severe hearing loss and the knowledge about reimbursement criteria of hearing implants of otorhinolaryngologists in a secondary setting in Brabant. The study group will consist of a maximum of 100 geographically selected otorhinolaryngologists aged 25-70 years in a secondary setting in Brabant. A subselection will be made from the reachable otorhinolaryngologists in the region of Brabant. Recruitment will be discontinued when a maximum of 100 otorhinolaryngologists has been reached. A specific questionnaire will be systematically reviewed with the participants during an interview in the first and third phase. There is no financial compensation for the participants.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date April 30, 2023
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 70 Years
Eligibility Inclusion Criteria: - Otorhinolaryngologists working in a secondary setting - Dutch and French speaking Exclusion Criteria: - Otorhinolaryngologists working in a tertiary setting attached to a university

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Interview
This will be evaluated through a specific questionnaire that will be systematically gone over with the participants during an interview in the first and third phases.

Locations

Country Name City State
Belgium UZ Brussel Brussel Vlaams-Brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Buchman CA, Gifford RH, Haynes DS, Lenarz T, O'Donoghue G, Adunka O, Biever A, Briggs RJ, Carlson ML, Dai P, Driscoll CL, Francis HW, Gantz BJ, Gurgel RK, Hansen MR, Holcomb M, Karltorp E, Kirtane M, Larky J, Mylanus EAM, Roland JT Jr, Saeed SR, Skarzynski H, Skarzynski PH, Syms M, Teagle H, Van de Heyning PH, Vincent C, Wu H, Yamasoba T, Zwolan T. Unilateral Cochlear Implants for Severe, Profound, or Moderate Sloping to Profound Bilateral Sensorineural Hearing Loss: A Systematic Review and Consensus Statements. JAMA Otolaryngol Head Neck Surg. 2020 Oct 1;146(10):942-953. doi: 10.1001/jamaoto.2020.0998. — View Citation

D'Haese PSC, De Bodt M, Van Rompaey V, Van de Heyning P. Awareness of Hearing Loss in Older Adults: Results of a Survey Conducted in 500 Subjects Across 5 European Countries as a Basis for an Online Awareness Campaign. Inquiry. 2018 Jan-Dec;55:46958018759421. doi: 10.1177/0046958018759421. — View Citation

Sorkin DL. Access to cochlear implantation. Cochlear Implants Int. 2013 Mar;14 Suppl 1:S1. doi: 10.1179/1467010013Z.00000000081. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Behavior change: Questionnaire Change in referral pattern through study completion, an average of 1 year
Primary Knowledge: Questionnaire: Increased knowledge of hearing implant interventions and reimbursement criteria among otorhinolaryngologists in a secondary setting. through study completion, an average of 1 year
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