NCT04942327

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 18, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

October 29, 2021

Status Verified

May 1, 2021

Enrollment Period

9 months

First QC Date

May 28, 2021

Last Update Submit

October 27, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Behavior change: Questionnaire

    Change in referral pattern

    through study completion, an average of 1 year

  • 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

Study Arms (1)

Interview

OTHER

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.

Behavioral: Interview

Interventions

InterviewBEHAVIORAL

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.

Interview

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Otorhinolaryngologists working in a secondary setting
  • Dutch and French speaking

You may not qualify if:

  • Otorhinolaryngologists working in a tertiary setting attached to a university

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Brussels, Vlaams-Brabant, 1000, Belgium

RECRUITING

Related 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.

    PMID: 32857157BACKGROUND
  • 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.

    PMID: 29529899BACKGROUND
  • Sorkin DL. Access to cochlear implantation. Cochlear Implants Int. 2013 Mar;14 Suppl 1(Suppl 1):S1. doi: 10.1179/1467010013Z.00000000081. No abstract available.

    PMID: 23453144BACKGROUND

Related Links

MeSH Terms

Conditions

Hearing Loss

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Vedat Topsakal, Professor

    UZ Brussel / VUB

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Tryhou, Bachelor

CONTACT

Patrick D'Haese, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2021

First Posted

June 28, 2021

Study Start

August 18, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2023

Last Updated

October 29, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations