Clinical trial NCT04864912: Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery
Official title: A Retrospective Mapping of Health Care Utilisation and Current Quality of Life Status in Adult Subjects With a History of Chronic Otitis Media With or Without Cholesteatoma Who Have Undergone a Primary Tympanoplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Otitis Media
Keywords: Primary tympanoplasty
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: QbD Clinical
name: Suministros Hospitalarios Medical Group
First posted: 2021-04-29
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with a history of chronic otitis media who have undergone a primary tympanoplasty to improve hearing between 2010-2016 but still have conductive or mixed hearing loss.

Brief 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.


Eligibility criteria: 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 and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this study.

For France only:

* Subjects who are not affiliated to social security.
* Subjects who are under legal protection.

Primary outcomes:
measure: Number and Type of Contacts With Health Care Providers
timeFrame: From primary tympanoplasty to time of enrolment, up to 13 years
measure: Number and Type of Interventions and/or Procedures
timeFrame: From primary tympanoplasty to time of enrolment, up to 13 years
measure: Number and Type of Medications and Therapies
timeFrame: From primary tympanoplasty to time of enrolment, up to 13 years
Secondary outcomes:
measure: Hearing Performance Assessed Via an Audiogram
timeFrame: Up to 12 months prior to primary tympanoplasty
measure: Hearing Performance Assessed Via an Audiogram
timeFrame: Within 12 months after primary tympanoplasty
measure: Hearing Performance Assessed Via an Audiogram
timeFrame: Up to 6 years prior to study enrollment
measure: Health Care Costs
timeFrame: From primary tympanoplasty to time of enrolment.
measure: Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
timeFrame: At enrolment
measure: Self-reported Health Status and Health Related Quality of Life Via the Health Utilities Index Mark III (HUI3) Questionnaire.
timeFrame: At enrolment
measure: Self-reported Health Related Quality of Life of Participants With COM Via the Chronic Otitis Media Outcome Test-15 (COMOT-15) Questionnaire.
timeFrame: At enrolment
measure: Self-reported Auditory Disability Via the Speech, Spatial and Qualities of Hearing Scale (SSQ-12) Questionnaire
timeFrame: At enrolment
measure: Chronic Otitis Media Outcome Test -15 (COMOT-15) Questionnaire in German, French and Spanish
timeFrame: At enrollment
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre, Hôpitaux universitaires Paris Sud AP-HP
city: Toulouse
country: France
facility: ENT department - Bâtiment Pierre Paul Riquet - Hôpital Purpan
city: Freiburg
country: Germany
facility: Universitätsklinik für Hals-, Nasen und Ohrenheilkunde
city: Heidelberg
country: Germany
facility: Hals-, Nasen- und Ohrenklinik, Universitätsklinikum Heidelberg
city: Donostia
country: Spain
facility: Hospital Universitario Donostia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Cochlear
name: Christiane D'hondt
role: STUDY_DIRECTOR
References: