Arabic Version of a New Tool Called HEAL-COMMAND to Evaluate Hearing Loss and Communication and Conversation Disability

Hearing Loss Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05543148
• Other study ID #: Soh-Med-22-09-04
• Status: Not yet recruiting
• Start date: October 2022
• Est. completion date: March 2023

Study information

• Verified date: September 2022
• Source: Sohag University
• Contact: Mahmoud Salah Mokhtar, resident
• Phone: 01093678921
• Email: mahmoud011173[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Other:
• Questionnaire
Evaluate hearing loss and communication and conversation disabilities

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pilot the validity of an Arabic version of HEAL-COMMAND Tool	There is 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. The primary aim is to pilot the validity of the Arabic version of the HEAL COMMAND Tool at the Audio-vestibular medicine unit. We will investigate the content validity of the items of the Arabic version of the questionnaire as an evaluation instrument, including the reliability and psychometric aspects of the instrument. Qualitative (cognitive interview) and quantitative (questionnaire) data collection and analysis will be completed in parallel with other sites in USA and Germany over 30 participant. the consolidated version will be tested in another cohort over 50 participants in which they will be asked to complete the questionnaire only	5 months, the first 2 months to create the consolidated version and 3 months to test it in another cohort