Validation of a Questionnaire for Measuring Quality of Life in Patients With Chronic Inflammation of the Middle Ear
May 7, 2024 updated by: University of Zurich
Validation of a Questionnaire for Measuring Health-related Quality of Life in Patients With Chronic Otitis Media
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
See Summary that contains all the details
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zürich, Switzerland, 8091
- Universitätsspital Zürich
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
patients suffering from chronic otitis media, visiting a tertiary referral centre
Description
Inclusion Criteria:
- clinical diagnosis of chronic otitis media
Exclusion Criteria:
none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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questionnaire
Otitis patients and controls
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Validity
Time Frame: day 1 (day of consultation)
|
Several aspects of Validity will be determined by different methods:
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day 1 (day of consultation)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alexander Huber, M.D., Universitätsspital Zürich
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
August 14, 2014
First Submitted That Met QC Criteria
August 25, 2014
First Posted (Estimated)
August 27, 2014
Study Record Updates
Last Update Posted (Actual)
May 9, 2024
Last Update Submitted That Met QC Criteria
May 7, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRQOL-COM1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.