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
NCT number | NCT04864912 |
Other study ID # | CBAS5780 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2022 |
Est. completion date | October 9, 2023 |
Verified date | December 2023 |
Source | Cochlear |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Cochlear | QbD Clinical, Suministros Hospitalarios Medical Group |
France, Germany, Spain,
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 |
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