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

NCT05543148 | Unknown

• 1 other identifier: Soh-Med-22-09-04
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

normal hearing with subjective hearing difficulty

Other: Questionnaire

mild hearing loss (unaided)

Other: Questionnaire

moderate hearing loss (unaided)

Other: Questionnaire

moderate hearing loss (aided)

Other: Questionnaire

Interventions

Questionnaire OTHER

Evaluate hearing loss and communication and conversation disabilities

mild hearing loss (unaided); moderate hearing loss (aided); moderate hearing loss (unaided); normal hearing with subjective hearing difficulty

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age between 30-80 years
• 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
• Adequate cognitive and comprehension abilities to complete the questionnaire and cognitive interview session.
• Ability to attend remote activities

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Hearing Loss

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Mahmoud Salah Mokhtar, resident

CONTACT

01093678921; mahmoud011173@med.sohag.edu.eg

Mohamed Abd Al-Rahman, professor

CONTACT

01099055507; dr_mghaffar@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Audio-vestibular medicine unit, ENT department Sohag university

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 16, 2022
• Study Start: October 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: September 16, 2022

Record last verified: 2022-09