Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery

Chronic Otitis Media Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04864912
• Other study ID #: CBAS5780
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: October 9, 2023

Study information

• Verified date: December 2023
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: October 9, 2023
• Est. primary completion date: October 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Otitis Media
• Otitis
• Otitis Media

Intervention

Other:
• Questionnaires and survey
Questionnaires: Health Utilities Index Mark III, Chronic Otitis Media Outcome Test-15 and Speech, Spatial, and Qualities of Hearing Scale-12 Survey: Client Service Receipt Inventory (adapted version)

Locations

Country	Name	City	State
France	Hôpital Bicêtre, Hôpitaux universitaires Paris Sud AP-HP	Le Kremlin-Bicêtre
France	ENT department - Bâtiment Pierre Paul Riquet - Hôpital Purpan	Toulouse
Germany	Universitätsklinik für Hals-, Nasen und Ohrenheilkunde	Freiburg
Germany	Hals-, Nasen- und Ohrenklinik, Universitätsklinikum Heidelberg	Heidelberg
Spain	Hospital Universitario Donostia	Donostia
Spain	Hospital Universitario Virgen Macarena	Sevilla

Sponsors (3)

Lead Sponsor	Collaborator
Cochlear	QbD Clinical, Suministros Hospitalarios Medical Group

Countries where clinical trial is conducted

France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and type of contacts with health care providers	Contacts are obtained from medical records, counted and categorized.	From primary tympanoplasty to time of enrolment, up to 13 years
Primary	Number and type of interventions and/or procedures	Medical examinations, surgical procedures and hearing rehabilitation are obtained from medical records, counted and categorized.	From primary tympanoplasty to time of enrolment, up to 13 years
Primary	Number and type of medications and therapies	Medications are obtained from medical records, counted and categorized. Therapies from medical records are listed.	From primary tympanoplasty to time of enrolment, up to 13 years
Secondary	Hearing performance assessed via an audiogram	PTA4 (0.5, 1, 2 and 4 kHz) for both air and bone conduction, under unaided and when applicable aided conditions. Data obtained from participant medical records.	Pre-primary tympanoplasty
Secondary	Hearing performance assessed via an audiogram	PTA4 (0.5, 1, 2 and 4 kHz) for both air and bone conduction, under unaided and when applicable aided conditions. Data obtained from participant medical records.	Post- primary tympanoplasty during follow-up appointment (clinic dependent)
Secondary	Hearing performance assessed via an audiogram	PTA4 (0.5, 1, 2 and 4 kHz) for both air and bone conduction, under unaided and when applicable aided conditions. Data obtained from participant medical records.	Between 2018 and the time of enrolment
Secondary	Health care costs	Direct medical costs associated to Chronic Otitis Media (COM)-related health care utilisation are obtained from medical records and calculated for each participant using unit cost in each participating country	From primary tympanoplasty to time of enrolment.
Secondary	Socio-economic status and health care data via the Client Service Receipt Inventory (CSRI) survey	Demographic data, medical history, hearing rehabilitation, health care utilisation related to ear infection and hearing difficulties and employment information data are collected.	At enrolment
Secondary	Self-reported health status and health related quality of life via the Health Utilities Index Mark III (HUI3) questionnaire.	HUI provides descriptive evidence on multiple dimensions of health status, a score for each dimension of health and an overall Health Related Quality of life score. The HUI3 classification system is comprised of 8 attributes: Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition and Pain - each with 5 or 6 levels of ability/disability The scoring systems provide utility (preference) scores on a generic scale where 0.00 indicates death and 1.00 indicates perfect health.	At enrolment
Secondary	Self-reported health related quality of life of participants with COM via the Chronic Otitis Media Outcome Test-15 (COMOT-15) questionnaire.	COMOT-15 measures Health Related Quality of life of participants with COM. It consists of three subscales: ear symptoms, hearing function, and mental health forming the overall score. In addition, two questions related to COM are asked: one on the general evaluation of quality of life and one on the frequency of doctor visits in the last six months. The total score and the sub-scores are transformed to a 0-100 scale by dividing the sum of the raw scores of the items by the sum of spans of the items, then multiplying by 100. A higher score indicates a worse health-related quality of life.	At enrolment
Secondary	Self-reported auditory disability via the Speech, Spatial and Qualities of Hearing Scale (SSQ-12) questionnaire	SSQ-12 measures speech, spatial and hearing experiences. The total score summarizes these parameters. A scale from 0 to 10 is used. A mark 0 means "be quite unable to do or experience what is described" and a mark 10 means "be perfectly able to do or experience what is described in the question".	At enrolment
Secondary	Validation of the COMOT-15 questionnaire in French and Spanish	Questionnaire to be completed by a minimum of 30 participants per language with an accompanying audiogram done within 12 months of questionnaire completion. The Cronbach's alpha value of 0.7 is used as a cut-off to measure consistency between the data.	Within one year of questionnaire completion