SOUND-BITES Hearing Health Checks for MoW Clients, NSW

Trial Review

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Registration number

ACTRN12626000512325 Ethics application status

Approved Date submitted

2/04/2026 Date registered

24/04/2026 Date last updated

24/04/2026 Date data sharing statement initially provided

24/04/2026 Type of registration

Prospectively registered
Titles & IDs Public title Home Hearing Health Checks for Meals on Wheels Clients Query! Scientific title SOUND-BITES - Acceptability and feasibility of embedding home hearing health checks in NSW Meals on Wheels Clients Query! Additional trial identifiers [1] 316888 0 None Query! Universal Trial Number (UTN) Query! Trial acronym Query! Related trial records Query!
Health condition Health condition(s) studied: Hearing Loss 341284 0 Query! Condition category Condition code Ear 337355 337355 0 0 Query! Deafness Query!

Intervention/exposure Study type Interventional Query! Description of the intervention or exposure Hearing health checks for consenting Meals on Wheels Clients will be conducted by Master of Clinical Audiology students together with Meals on Wheels volunteers in clients' homes. This hearing health check will be scheduled as a new visit, separate from the services that Meals on Wheels clients usually receive. The hearing health check will take approximately 30 minutes. The hearing health check includes the otoscopic examination of the ear using the Arclight device and a hearing screening assessment using the Sound Scouts iPad application, which will be conducted by the Audiology student and supported by the volunteer. Results will be explained and further follow-up with GP and/or audiologist will be recommended as required. Brief educational messages will be delivered by the student and volunteer including the importance of addressing hearing loss; and impacts of untreated hearing loss on quality of life, social life, and cognitive function. The students and/or volunteers will complete a checklist to ensure all intervention procedures have been completed.
Audiology students will receive a 1-hour training session to familiarise themselves with the equipment used and research study procedures. Meals on Wheels Volunteers will attend a 3-hour training session. The training session will be delivered by research study staff and will occur within 3 weeks of the program being rolled out at the Meals on Wheels site. The training will cover:
1. General education about hearing health
2. Overview of the hearing health assessment using the Sound Scouts app and Arclight device
3. Overview of the hearing assessment feedback given to clients
4. Overview of the client hearing health education
5. Administrative procedures that volunteers need to follow to deliver the SOUND-BITES program.
Query! Intervention code [1] 333583 0 Early detection / Screening Query! Description of the comparator or control No control group Query! Control group Uncontrolled Query!
Outcomes Primary outcome [1] 344874 0 Acceptability of the program by MoW Clients Query! Timepoint [1] 344874 0 Interview completed within 4 weeks of hearing health assessment Query! Primary outcome [2] 344956 0 Acceptability of the program by MoW Volunteers Query! Timepoint [2] 344956 0 Interview completed within 4 weeks of participating in the delivery of the hearing health assessment Query! Primary outcome [3] 345112 0 Feasibility of the program by MoW Clients Query! Timepoint [3] 345112 0 Interview completed within 4 weeks of hearing health assessment Query! Secondary outcome [1] 459585 0 Health-seeking behaviour of MoW Clients Query! Timepoint [1] 459585 0 6-months post assessment Query! Secondary outcome [2] 459908 0 Quality of Life Query! Timepoint [2] 459908 0 Baseline, 6 months post assessment Query! Secondary outcome [3] 459909 0 Subjective hearing handicap Query! Timepoint [3] 459909 0 Baseline, 6-months post assessment Query! Secondary outcome [4] 459910 0 Hearing Disability across three domains, speech hearing, spatial hearing and qualities of hearing Query! Timepoint [4] 459910 0 Baseline, 6-months post assessment Query! Secondary outcome [5] 459911 0 Falls History Query! Timepoint [5] 459911 0 Baseline, 6-months post assessment Query! Secondary outcome [6] 459912 0 Otoscopic Examination of Ear Query! Timepoint [6] 459912 0 At time of assessment Query! Secondary outcome [7] 459913 0 Hearing Loss Query! Timepoint [7] 459913 0 At time of assessment Query! Secondary outcome [8] 460513 0 Feasibility of the program by MoW Volunteers
Note this is a Primary Outcome Query! Timepoint [8] 460513 0 Interview completed within 4 weeks of participating in the delivery of the hearing health assessment Query!
Eligibility Key inclusion criteria MoW Volunteers:
• MoW volunteer at a participating service
• Aged 18 years or older
• Willingness and ableness to attend training sessions and deliver the hearing health checks and education

MoW Clients:
• MoW client at a participating service
• Aged 50 years or older
• Have sufficient English language competency to understand instructions and complete the questionnaires
• Able to provide own informed consent

Query! Minimum age 18 Years Query! Query! Maximum age No limit Query! Query! Sex Both males and females Query! Can healthy volunteers participate? Yes Query! Key exclusion criteria MoW Volunteers:
• Insufficient English language competency to undergo training and deliver hearing health checks in conjunction with MClinAudiology Students

MoW Clients:
• Diagnosed cognitive impairment such as dementia
• Currently using a hearing aid and/or cochlear implant regularly (on average >2 hours/day)
Query!
Study design Purpose of the study Diagnosis Query! Allocation to intervention Non-randomised trial Query! Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures) Query! Methods used to generate the sequence in which subjects will be randomised (sequence
generation) Query! Masking / blinding Open (masking not used) Query! Who is / are masked / blinded?

Query! Query! Query! Query! Intervention assignment Single group Query! Other design features Query! Phase Not Applicable Query! Type of endpoint/s Query! Statistical methods / analysis Query!
Recruitment Recruitment status Not yet recruiting Query! Date of first participant enrolment Anticipated 4/05/2026 Query! Actual Query! Date of last participant enrolment Anticipated 12/10/2026 Query! Actual Query! Date of last data collection Anticipated 30/04/2027 Query! Actual Query! Sample size Target 600 Query! Accrual to date Query! Final Query! Recruitment in Australia Recruitment state(s) NSW Query!
Funding & Sponsors Funding source category [1] 321401 0 University Query! Name [1] 321401 0 Macquarie University Query! Country [1] 321401 0 Australia Query! Funding source category [2] 321482 0 Commercial sector/Industry Query! Name [2] 321482 0 Cochlear Query! Country [2] 321482 0 Australia Query! Funding source category [3] 321483 0 Commercial sector/Industry Query! Name [3] 321483 0 NSW Smart Sensing Network Query! Country [3] 321483 0 Australia Query! Primary sponsor type University Query! Name Macquarie University Query! Address Query! Country Australia Query! Secondary sponsor category [1] 324300 0 None Query! Name [1] 324300 0 Query! Address [1] 324300 0 Query! Country [1] 324300 0 Query!
Ethics approval Ethics application status Approved Query! Ethics committee name [1] 319942 0 Macquarie University Human Research Ethics Committee Medical Sciences Query! Ethics committee address [1] 319942 0 https://www.mq.edu.au/research/ethics-integrity-and-policies/ethics/human-ethics Query! Ethics committee country [1] 319942 0 Australia Query! Date submitted for ethics approval [1] 319942 0 07/08/2025 Query! Approval date [1] 319942 0 11/12/2025 Query! Ethics approval number [1] 319942 0 Query!
Summary Brief summary There is a high prevalence of undiagnosed and untreated hearing loss among older adults. To improve access to hearing health care, the SOUND-BITES program will pilot a novel method of delivering hearing health assessments with MoW Clients. Master of Clinical Audiology students partnered with MoW Volunteers will complete hearing health checks of MoW Clients in their own homes. The hearing health checks include otoscopic examination of the ear using the Arclight otoscope and hearing loss screening using the Sound Scouts hearing screening app. MoW clients will be referred for further assessment where indicated. Education will be provided on the importance of looking after hearing health by the Audiology Students and MoW Volunteers. Query! Trial website Query! Trial related presentations / publications Query! Public notes Query!
Contacts Principal investigator Name 148898 0 Prof Bamini Gopinath Query! Address 148898 0 The Australian Hearing Hub 16 University Avenue Macquarie University Macquarie Park NSW 2109 Query! Country 148898 0 Australia Query! Phone 148898 0 +61 298508962 Query! Fax 148898 0 Query! Email 148898 0 [email protected] Query! Contact person for public queries Name 148899 0 Jessica Turner Query! Address 148899 0 The Australian Hearing Hub 16 University Avenue Macquarie University Macquarie Park NSW 2109 Query! Country 148899 0 Australia Query! Phone 148899 0 +61 40481863983 Query! Fax 148899 0 Query! Email 148899 0 [email protected] Query! Contact person for scientific queries Name 148900 0 Bamini Gopinath Query! Address 148900 0 The Australian Hearing Hub 16 University Avenue Macquarie University Macquarie Park NSW 2109 Query! Country 148900 0 Australia Query! Phone 148900 0 +61 298508962 Query! Fax 148900 0 Query! Email 148900 0 [email protected] Query!
Data sharing statement Will the study consider sharing individual participant data? Yes
Will there be any conditions when requesting access to individual participant data? Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
What individual participant data might be shared? • All de-identified individual participant data
What types of analyses could be done with individual participant data? • Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)? From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly? • Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data? Yes: Costs and institutional data sharing policies

What supporting documents are/will be available?

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.