Hearing LossNCT05543148
Arabic Version of a New Tool Called HEAL-COMMAND to Evaluate Hearing Loss and Communication and Conversation Disability
An observational study of Hearing Loss, run by Sohag University.
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… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Questionnaire
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be patients from Audio-Vestibular Medicine Unit Sohag university who complained of hearing loss or seeking hearing aid technology
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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
- Being tested
- Questionnaire
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Evaluate hearing loss and communication and conversation disabilities
| Study group | Role | What they receive |
|---|---|---|
| normal hearing with subjective hearing difficulty | Not described Receives: Other: Questionnaire | |
| mild hearing loss (unaided) | Not described Receives: Other: Questionnaire | |
| moderate hearing loss (unaided) | Not described Receives: Other: Questionnaire | |
| moderate hearing loss (aided) | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 months, the first 2 months to create the consolidated version and 3 months to test it in another cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Salah Eldin Mokhtar, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543148
- Sponsor's protocol ID
- Soh-Med-22-09-04
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05543148
- Acronym / sponsor ID
- Soh-Med-22-09-04
- Conditions
- Hearing Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be patients from Audio-Vestibular Medicine Unit Sohag university who complained of hearing loss or seeking hearing aid technology
Key inclusion criteria (8 listed)
- 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:
- Adequate cognitive and comprehension abilities to complete the questionnaire and cognitive interview session.
- Ability to attend remote activities
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireEvaluate hearing loss and communication and conversation disabilities | Other | mild hearing loss (unaided), moderate hearing loss (aided), moderate hearing loss (unaided), normal hearing with subjective hearing difficulty |
Primary outcome
Pilot the validity of an Arabic version of HEAL-COMMAND Tool
Time frame: 5 months, the first 2 months to create the consolidated version and 3 months to test it in another cohort
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Salah Mokhtar, resident (01093678921, mahmoud011173@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pilot the validity of an Arabic version of HEAL-COMMAND Tool (time frame: 5 months, the first 2 months to create the consolidated version and 3 months to test it in another cohort). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.