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临床试验/NCT06108609
NCT06108609已完成不适用

Validation of the French Version of the Hearing Aid Benefit Measurement COSI and IOI-HA Questionnaires

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Statistical validation of the French version of the IOI-HA and COSI questionnaires: Reproducibility, internal consistency, relevance and discriminatory performance of the tests

研究概览

简要总结

Estimating patient satisfaction is essential in modern day-to-day medical practice. This is particularly true in the field of audiology where evaluating the benefit of patients' devices makes it possible to improve settings and increase patient satisfaction and therefore compliance. Questionnaires measuring hearing aid benefit such as the IOI-HA (International Outcome Inventory for Hearing Aids) and the COSI (Client Oriented Scale of Improvement) are used in everyday practice and promote cooperation between researchers by providing comparable data. Unlike other countries, these questionnaires have never been validated in French by psychometric studies. The objective of this study is to validate the translation of the IOI-HA questionnaire already used in the clinic and to adapt the COSI into French and statistically validate its translation.

详细描述

Recruitment of cases via the otological consultation of the ENT department, among patients consulting for hearing aids. Inclusion will be suspended once 100 tests and at least 35 re-tests have been completed.

Inclusion (D0):

  • Audiometry (as part of treatment)
  • Clinical evaluation (as part of treatment)
  • Passing the French version of the COSI and IOI-HA questionnaires Visit 1 (D0 +3±1 week): only for 35 patients Second administration of the French version of the COSI and IOI-HA questionnaires either by telephone, or during a second consultation or hospitalization, if this occurs within a compatible time frame.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients > 18 years old
  • Diagnosis of deafness with unilateral or bilateral hearing aid
  • Informed consent to participate in the study
  • Good understanding of French
  • Non-opposition to participation in the study

排除标准

  • Comorbidity that may hamper the interpretation of results (e.g. disabling cognitive disorder)

结局指标

主要结局

Statistical validation of the French version of the IOI-HA and COSI questionnaires: Reproducibility, internal consistency, relevance and discriminatory performance of the tests

时间窗: 3 +/- 1 week

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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