Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis M… (NCT04864912) | Clinical Trial Compass
CompletedNot Applicable
Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery
France, Germany, Spain69 participantsStarted 2022-02-01
Plain-language summary
The objective of this multicentre study is to evaluate the standard of care of participants diagnosed with Chronic Otitis Media that have already gone through a first middle ear surgery but still have at least a moderate hearing loss. The study has a retrospective part (extraction of medical chart data) and a prospective part with a survey and three questionnaires collecting data on the use of health care services, on health related quality of life and hearing performance.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult subjects, 18 years or older.
* Subjects with conductive or mixed hearing loss.
* Subjects with historically documented diagnosis of Chronic Otitis Media (COM) with or without cholesteatoma in the operated ear.
* Subjects who have undergone primary tympanoplasty type I-V to improve hearing between 2010-2016.
* Subjects with a Pure Tone Average (PTA)4 air-bone gap ≥30 decibels (dB) OR PTA4 air-bone gap between 25-30 dB with an air conduction threshold PTA4 ≥40 dB HL within 12 months after primary tympanoplasty in the operated ear.
* Subjects who have been recommended by their health care professional to try a hearing aid to improve hearing in the operated ear.
* Pre-op audiogram, maximum 1 year prior to the primary tympanoplasty, and post-op audiogram for the primary tympanoplasty are available.
* Aided audiogram, unaided if no hearing device is used, available between 2018 and the point of enrolment.
* Subjects are fluent in the language used for study questionnaires: German, French, Spanish.
* Subjects are willing and able to provide written informed consent. For France: subjects do not oppose to participate in the study.
* Medical Record data is available throughout the defined data search period, from primary tympanoplasty to point of enrolment.
Exclusion Criteria:
* Subjects are unable or unwilling to comply with the requirements of the study as determined by the investigator.
* Investigator site personnel directly affiliated with this study …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number and Type of Contacts With Health Care Providers
Timeframe: From primary tympanoplasty to time of enrolment, up to 13 years
2
Number and Type of Interventions and/or Procedures
Timeframe: From primary tympanoplasty to time of enrolment, up to 13 years
3
Number and Type of Medications and Therapies
Timeframe: From primary tympanoplasty to time of enrolment, up to 13 years