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

September 14, 2022 updated by: Mahmoud Salah Eldin Mokhtar, Sohag University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
normal hearing with subjective hearing difficulty
Other: Questionnaire
Evaluate hearing loss and communication and conversation disabilities
mild hearing loss (unaided)
Other: Questionnaire
Evaluate hearing loss and communication and conversation disabilities
moderate hearing loss (unaided)
Other: Questionnaire
Evaluate hearing loss and communication and conversation disabilities
moderate hearing loss (aided)
Other: Questionnaire
Evaluate hearing loss and communication and conversation disabilities

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
5 months, the first 2 months to create the consolidated version and 3 months to test it in another cohort

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Soh-Med-22-09-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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