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

  • Switzerland
      • Zürich, Switzerland, 8091
        • UniversitätsSpital Zürich

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
questionnaire
Otitis patients and controls
Other: Administration of questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity
Time Frame: day 1 (day of consultation)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

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.

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