Clinical trial NCT05543148: Arabic Version of a New Tool Called HEAL-COMMAND to Evaluate Hearing Loss and Communication and Conversation Disability
Official title: Toward An Arabic Version of HEAL-COMMAND Tool: A New International Self-Rated ICF-Based Questionnaire to Evaluate Hearing Loss and Communication and Conversation Disability
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing Loss
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be patients from Audio-Vestibular Medicine Unit Sohag university who complained of hearing loss or seeking hearing aid technology

Brief summary: Hearing loss is the fourth highest cause of disability globally. Current data suggest that approximately 5% of the world's population suffer from disabling hearing loss, Earlier studies have shown that persons with hearing loss experience a higher prevalence of associated adverse health effects than persons with normal hearing. Those conditions include social isolation, depression, diabetes, dementia, falling, cardiovascular disease, and reduced quality of life. A limitation to disability-based questionnaires related to hearing loss is the large number of instruments available and the lack of consensus on which questionnaires to use. To do so, applying the World Health Organization's International Classification of Functioning Disability and Health (ICF) framework was found to be an ideal design foundation. In the ICF, functioning refers to positive aspects of Body Functions, Activities, and Participation, while disability refers to impairments, activity limitations, and participation restrictions, in which both aspects can be influenced by a health condition(s) and or contextual (personal and environmental) factors. Previous studies showed that the operationalization of the ICF Core Sets for HL into a self-assessment tool can serve as the foundation for a comprehensive picture of health. To accommodate this need, a collaboration between group of researchers at Audiology Clinic, Auburn university, Alabama, USA have been conducted. This partnership resulted in creating an English and German version of questionnaire that comprehensively assesses and individuals hearing functioning profile according to ICF framework which is called HEAL-COMMAND Tool


Eligibility criteria: Inclusion Criteria:

1. Age between 30-80 years
2. New individuals who presented to the speech and hearing clinic with ear or hearing complaints and showed the following pattern/s:

   * Normal hearing with subjective hearing difficulties
   * Mild hearing Loss
   * Moderate hearing loss
   * New hearing aid users or experienced hearing aid users
3. Adequate cognitive and comprehension abilities to complete the questionnaire and cognitive interview session.
4. Ability to attend remote activities

Exclusion Criteria:

1. age under 30 or over 80 years
2. illiterate who can't complete the questionnaire or digital forms
3. clinical diagnosis with depression and cognitive decline or dementia
4. Above moderate hearing loss

Primary outcomes:
measure: Pilot the validity of an Arabic version of HEAL-COMMAND Tool
timeFrame: 5 months, the first 2 months to create the consolidated version and 3 months to test it in another cohort
Secondary outcomes:
Other outcomes:
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