Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of a Questionnaire for Measuring Quality of Life in Patients With Chronic Inflammation of the Middle Ear

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02226718
Recruitment Status : Unknown
Verified August 2014 by University of Zurich.
Recruitment status was:  Not yet recruiting
First Posted : August 27, 2014
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief 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.

Condition or disease Intervention/treatment
Chronic Otitis Media Other: Administration of questionnaire

Layout table for study information
Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a Questionnaire for Measuring Health-related Quality of Life in Patients With Chronic Otitis Media
Study Start Date : October 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Group/Cohort Intervention/treatment
questionnaire Other: Administration of questionnaire



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients suffering from chronic otitis media, visiting a tertiary referral centre
Criteria

Inclusion Criteria:

  • clinical diagnosis of chronic otitis media

Exclusion Criteria:

none


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226718


Contacts
Layout table for location contacts
Contact: Alexander Huber, M.D. +41 44 255 58 60 alex.huber@usz.ch

Locations
Layout table for location information
Switzerland
Universitätsspital Zürich Not yet recruiting
Zürich, Switzerland, 8091
Contact: Alexander Huber, M.D.    +41 44 255 58 60    alex.huber@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
Layout table for investigator information
Principal Investigator: Alexander Huber, M.D. Universitätsspital Zürich

Layout table for additonal information
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02226718     History of Changes
Other Study ID Numbers: HRQOL-COM1
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: August 27, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases