Chronic Otitis MediaNCT02226718
Validation of a Questionnaire for Measuring Quality of Life in Patients With Chronic Inflammation of the Middle Ear
An observational study of Chronic Otitis Media, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Otitis Media
- What is being tested?
- Administration of questionnaire
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2014to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients suffering from chronic otitis media, visiting a tertiary referral centre
Who may be able to join
- clinical diagnosis of chronic otitis media
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
See Summary that contains all the details
- Conditions
- Chronic Otitis Media
- Being tested
- Administration of questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of questionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| questionnaire | Otitis patients and controls Receives: Other: Administration of questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 1 (day of consultation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Otitis MediaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Huber, M.D., Principal investigator, Universitätsspital Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226718
- Sponsor's protocol ID
- HRQOL-COM1
- Status last verified
- May 2024
- First submitted
- 14 Aug 2014
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Questionnaire for Measuring Health-related Quality of Life in Patients With Chronic Otitis Media
- ClinicalTrials.gov ID
- NCT02226718
- Acronym / sponsor ID
- HRQOL-COM1
- Conditions
- Chronic Otitis Media
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
See Summary that contains all the details
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| questionnaire | – | Other: Administration of questionnaireOtitis patients and controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients suffering from chronic otitis media, visiting a tertiary referral centre
Key inclusion criteria (1 listed)
- clinical diagnosis of chronic otitis media
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of questionnaire | Other | questionnaire |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Huber, M.D. principal investigator
Universitätsspital Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Otitis Media, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity (time frame: day 1 (day of consultation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.