Chronic Otitis Media Clinical Trial
Official title:
Validation of a Questionnaire for Measuring Health-related Quality of Life in Patients With Chronic Otitis Media
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 |
Verified date | May 2024 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Universitätsspital Zürich | Zürich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
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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