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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 69
- 试验地点
- 6
- 主要终点
- Number and Type of Contacts With Health Care Providers
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
结局指标
主要结局
Number and Type of Contacts With Health Care Providers
时间窗: From primary tympanoplasty to time of enrolment, up to 13 years
Contacts are obtained from medical records, counted and categorized.
Number and Type of Interventions and/or Procedures
时间窗: From primary tympanoplasty to time of enrolment, up to 13 years
Medical examinations, surgical procedures and hearing rehabilitation are obtained from medical records, counted and categorized.
Number and Type of Medications and Therapies
时间窗: From primary tympanoplasty to time of enrolment, up to 13 years
Medications are obtained from medical records, counted and categorized. Therapies from medical records are listed.
次要结局
- Hearing Performance Assessed Via an Audiogram(Up to 6 years prior to study enrollment)
- Health Care Costs(From primary tympanoplasty to time of enrolment.)
- Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey(At enrolment)
- Self-reported Health Status and Health Related Quality of Life Via the Health Utilities Index Mark III (HUI3) Questionnaire.(At enrolment)
- Self-reported Health Related Quality of Life of Participants With COM Via the Chronic Otitis Media Outcome Test-15 (COMOT-15) Questionnaire.(At enrolment)
- Self-reported Auditory Disability Via the Speech, Spatial and Qualities of Hearing Scale (SSQ-12) Questionnaire(At enrolment)
- Chronic Otitis Media Outcome Test -15 (COMOT-15) Questionnaire in German, French and Spanish(At enrollment)