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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02226718
Other study ID # HRQOL-COM1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2014
Est. completion date December 2018

Study information

Verified date May 2024
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

For measuring quality of life in patients with chronic inflammation of the middle ear, only two questionnaires currently exist. However, these questionnaires are designed only to measure either disease-specific health or hearing-related quality of life. The aim of this project is the validation of a pre-existing comprehensive questionnaire, which is routinely administered in the investigators clinic but has never been validated. Following a retrospective item reduction based on existing data, this questionnaire will be prospectively validated. Applying the resulting questionnaire in future studies on chronic middle ear inflammation, not only objective outcome parameters (e.g. audiograms) but also quality of life will be assessed. Therefore, the investigators questionnaire will add substantial information to these outcome studies by providing a subjective outcome parameter.


Description:

See Summary that contains all the details


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - clinical diagnosis of chronic otitis media Exclusion Criteria: none

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Administration of questionnaire


Locations

Country Name City State
Switzerland Universitätsspital Zürich Zürich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Validity Several aspects of Validity will be determined by different methods:
content validity is made certain by construction procedure of the questionnaire (e.g. involving of specialists and patients)
construct validity by factor analysis
criterion validity by correlating a global question with the overall questionnaire score
day 1 (day of consultation)
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