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Trial registered on ANZCTR

Registration number

ACTRN12624001167550

Ethics application status

Approved

Date submitted

15/08/2024

Date registered

25/09/2024

Date last updated

25/09/2024

Date data sharing statement initially provided

25/09/2024

Type of registration

Retrospectively registered

Titles & IDs

Public title

Evaluating the impact of hearing and vision support in home care settings

Scientific title

Implementation and evaluation of a home hearing and vision care program to improve quality of life for frail older Australians

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

hearing impairment

vision impairment

cognition

Mental well-being

Condition category

Condition code

Ear

Other ear disorders

Eye

Diseases / disorders of the eye

Neurological

Dementias

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention is a sensory support program for older adults (65y+) with hearing and/or vision impairment who receive home care services. Participants are (1) older adults with hearing and/or vision impairment who receive home care services, and (2) their informal caregiver (e.g., family or friend). Older adults without an informal caregiver are eligible to participate on their own.
The sensory support program is a complex intervention. It will be delivered over 3 months with 4 to 6 sessions (duration 1 to 2 hours) in the participant's home. The intervention will be delivered by a trained sensory therapist who is a qualified allied health professional (e.g., an audiologist or optometrist). The Sensory Therapist completed an online training course developed by the research team which took 16 hours. As well they receive 2 days of face-to-face training by the research team one month prior to first participant enrolment.
The program provides sensory support to older adults with cognition ranging from normal to moderately severe dementia. . The complete intervention comprises eight components:
1) Identifying sensory needs through a structured interview with the Sensory Therapist to develop their Personalised Sensory Plan,
2) Optimising vision/hearing impairment if required with updated hearing aids and/or spectacles (with Hearing Aids supplied by Starkey Hearing and/or $250 reimbursement towards new spectacles), and by organising appointment with community-based audiologist and/or optometrists and liaising with home care providers to organise transportation to the audiologist/optometrist,
3) Continuous training in correct use of sensory devices will be provided by the Sensory Therapist at each visit. They will provide the older adult and their informal caregiver information on the correct useage, wearing times, handling, maintenance, cleaning and storage of devices with knowledge tested by Hearing Aid Skills and Knowledge Test (HASK) and Glasses Skills and Knowledge Test (GLASK),
4) Home based functional assessment and goal setting: The Sensory Therapist will conduct a home based functional assessment via a structured interview, Using this information and the older adult's Personalised Sensory Plan, the Sensory Therapist will engage in a goal setting exercise with the older adult to determine what they would like to achieve out of the program.
5) Communication training provided by Sensory Therapist to both the older adult and their informal caregiver. Strategies on how to communicate in different settings and scenarios will be explored and discussed,
6) Referral to health and social services: Based on the functional assessments and goals set in component 4, the Sensory Therapist may refer the older adults to health or social care services in the community (e.g., psychological services, low vision services, geriatric psychiatry services, falls clinic, etc.) if required or desired.
7) Fostering social inclusion: In line with the participants' goals set in component 4, the Sensory Therapist will provide information and guidance on opportunities to develop the older adult's hobbies and interests or attend local social groups.
8) Environmental modifications and assistive devices : Based on the functional assessment and goals set in component 4, the Sensory Therapist may arrange and support the use of environmental modifications (e.g., lighting, increasing contrast) or assistive devices (e.g., Personal Amplifying devices, low vision devices, etc.,) to create an environment that supports the sensory needs of the older adult.
Each intervention component will be tailored to meet the participant's individual needs dependent on their cognitive ability, hearing and/or vision impairment, current knowledge and skills, access to services, and environmental factors.
The sensory support program resources are housed on a Learning Management System (Canvas Instructure). Participants will be enrolled as students in Canvas so that they can access and review the materials and resources at their leisure. Materials housed on Canvas comprise bespoke resources developed for the study as well as resources sourced from organisations.
Bespoke resources: Personalised Sensory Plan Questionnaire, Functional Assessment Questionnaire. Educational topics include: Correct usage of hearing/vision devices, One on one communication, Group communication, Written communication, Hearing and Vision Advocacy agencies, Healthy Ageing Advocacy agencies, Hobby/Activity Decision Aid, Audio Description & Subtitling, Modifying the Auditory Environment, Modifying the Visual Environment, Lighting, Modifying the Environment for People with Dementia, Assistive Technologies,
Other organisations: Bangor Goal Setting Inventory, Starkey Hearing (Videos – How to Guides for Hearing Aid Use), University of Nottingham (M2Hear Videos), SENSE-Cog Hearing Aids Skills & Knowledge Assessment (HASK), SENSE-Cog Glasses Skills & Knowledge Assessment (GLASK).
Strategies to assess adherence to the intervention: Adherence to intervention will check in various ways.(1) hearing aid and glasses correct useage will be assessed at each visit using the HASK and GLASK, (2) both the home care recipient and their informal caregivers will complete a logbook at the end of each visit. This will record the component(s) completed at that visit, any homework or practice they need to complete before next visit. In addition, they will rate the component on its feasibility, acceptability, and appropriateness in the logbooks, (3) the Sensory Therapist will complete a logbook for each visit documenting components completed, duration of visit, and any barriers and enablers to delivering the component, (4) the Sensory Therapist will complete a study logbook each week documenting, number of visits per day, costs incurred, and mileage,
The informal caregivers are included in this study to provide support to the older adults with hearing/vision impairment throughout the intervention. This includes attending the sessions with the sensory therapists whenever possible to learn about correct useage of devices and communication strategies, accompanying the older adults to visits to the audiologist/optometrist or other health or social care professionals or services, and helping the older adult to facilitate engagement in social activities as needed.

Intervention code [1]

Rehabilitation

Intervention code [2]

Lifestyle

Intervention code [3]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Health-related Quality of Life of older adults with hearing and/or vision impairment

Timepoint [1]

Baseline, 13 weeks (primary timepoint) and 26 weeks post commencement

Primary outcome [2]

Aged Care Consumer Quality of Life of older adults with hearing and/or vision impairment

Timepoint [2]

Baseline, 13 weeks (primary timepoint) and 26 weeks post commencement

Primary outcome [3]

Health Resources Used for informal caregivers

Timepoint [3]

Baseline, 13 weeks (primary time point) and 26 weeks post commencement

Secondary outcome [1]

Health Related Quality of Life of Informal Caregivers (primary outcome) for informal caregivers

Timepoint [1]

Baseline, 13 weeks and 26 weeks post commencement

Secondary outcome [2]

Social care-related quality of life (older adults with hearing and/or vision impairment) for older adults with hearing/vision impairment

Timepoint [2]

Baseline, 13 weeks and 26 weeks post commencement

Secondary outcome [3]

Activities of Daily Living (older adults with hearing and/or vision impairment)

Timepoint [3]

Baseline, 13 weeks and 26 weeks post commencement

Secondary outcome [4]

Hearing Function (older adults with hearing and/or vision impairment)

Timepoint [4]

Baseline, 13 weeks and 26 weeks post commencement

Secondary outcome [5]

Cognitive Function for older adults with hearing/vision impairment

Timepoint [5]

Baseline, 13 week, and 26 weeks post commencement

Secondary outcome [6]

Visual Function (older adults with hearing and/or vision impairment)

Timepoint [6]

Baseline, 13 weeks and 26 weeks post commencement

Secondary outcome [7]

Anxiety (older adults with hearing/vision impairment)

Timepoint [7]

Baseline, 13 weeks and 26 weeks post commencement

Secondary outcome [8]

Depression (older adults with hearing and/or vision impairment)

Timepoint [8]

Baseline, 13 weeks and 26 weeks post commencement

Secondary outcome [9]

Dementia Symptoms (older adults with hearing and/or vision impairment)

Timepoint [9]

Baseline, 13 weeks and 26 weeks post commencement

Secondary outcome [10]

Quality and quantity of Social Interactions (older adults with hearing and/or vision impairment) This will be assessed as a composite outcome.

Timepoint [10]

Baseline, 13 weeks and 26 weeks post commencement

Secondary outcome [11]

Quality of Relationship (Informal caregivers)

Timepoint [11]

Baseline, 13 weeks and 26 weeks post commencement

Secondary outcome [12]

Third-party hearing loss-related quality of life (informal caregiver)

Timepoint [12]

Baseline, 13 weeks and 26 weeks post commencement

Secondary outcome [13]

Implementation Outcome - Feasibility

Timepoint [13]

At the end of each sensory support program session

Secondary outcome [14]

Implementation Outcome - Appropriateness

Timepoint [14]

At the end of each sensory support program session

Secondary outcome [15]

Implementation Outcome - Fidelity

Timepoint [15]

At the end of each sensory support program session

Secondary outcome [16]

Implementation Outcome - Acceptability

Timepoint [16]

At the end of each sensory support program session

Secondary outcome [17]

Implementation Outcome - Contextual Issues

Timepoint [17]

Interviews will be conducted between week 10 to week 26 depending on participant availability.

Secondary outcome [18]

Cognitive function (informal caregivers)

Timepoint [18]

Baseline, 13 weeks and 26 weeks post intervention commencement

Secondary outcome [19]

Anxiety (informal caregivers)

Timepoint [19]

Baseline, 13 weeks and 26 weeks post-intervention commencement

Secondary outcome [20]

Depression (informal caregivers)

Timepoint [20]

Baseline, 13 weeks and 26 weeks post-intervention commencement

Eligibility

Key inclusion criteria

Participant Group 1 Older adults with hearing and/or vision: i) aged 65 years or older, ii) have cognition in the range from normal until the moderately-advanced stage of dementia (Stage 6, defined by the 7-stage FAST Score), iii) are a resident in their own home and receiving home care services; iv) have capacity to provide informed consent to participate, v) have adult-acquired hearing and/or vision impairment ( hearing worse than 20 dB HL at 1000Hz or worse than 35 dB HL at 3000Hz in the better ear; presenting monocular visual acuity of not more than 6/12 in the better eye.

Participant Group 2 Informal caregivers: i) aged 18 years or older, ii) are an informal caregiver of the older adult with hearing and/or vision impairment that is participating in the study, iii) able to provide consent, iv) have adequate conversational English.

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Participant Group 1 Older adults with hearing and/or vision impairment: People will be ineligible to participate if they have cataract(s) requiring surgical management within study period.

Participant Group 2 Informal Caregivers: People will be excluded if they are not in regular contact (less than weekly) with the older adults with hearing and/or vision impairment receiving receiving home care services.

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample Size: Approximately 87 home care recipients who meet the inclusion will be recruited to part 2. The evaluation is powered to detect a standardised effect size of d=0.3 (because hearing/vision interventions are associated with small-to-medium but meaningful effects on health-related quality of life outcomes) in the primary treatment group (i.e. people with hearing or vision loss). Assuming a correlation of 0.6 between baseline and 12-week follow-up Health Utility Indiex-3 scores and an attrition rate of 20% at follow-up (a conservative estimate based on the 12%–15% rates observed in previous similar studies), we will need to recruit 87 people with vision and/or hearing impairment at baseline to achieve 80% power to detect the effect size at the two-sided 5% level of significance.

Data analysis: To assess the impact of the program on quality of life the study will evaluate missing data, variability of outcomes and point estimates at baseline, end of intervention, and 3 months post-intervention. Changes in outcome measures will be estimated using multilevel linear or logistic regression models, including a random effect for each person to account for the repeated measures over time. Additionally, the study will explore the impact of sensory support on functional ability, visual and hearing function, mental and social well-being. Generalised linear models will analyse these dependent variables, with covariates including demographics, health status, cognitive functioning, sensory functioning and sensory support used. The nested data structure will be considered in the modelling. As well, the impact of sensory support on family member/informal caregiver well-being and relationship (RQ5) will also be assessed using similar models, accounting for the nested data structure. The precision of estimates will be assessed using 95% confidence intervals and significance set a p<.001.

The cost-effectiveness of the intervention compared with pre-intervention (care as usual) alternatives and the budget impact of its implementation at a national level will be modelled. The economic evaluation outcome will be the incremental cost-effectiveness ratio (ICER), which will determine whether the intervention is cost-effective using Australia’s cost-effectiveness threshold for QALYs. The lifetime cost-effectiveness of the intervention will be estimated using economic modelling (e.g., Markov modelling), with model structure and parameters not sourced from the trial informed by a literature review.
Descriptive statistics will be used to examine feasibility, appropriateness, and acceptability. We will analyse the process evaluation data quantitatively and qualitatively, using descriptive statistics and content analytic approaches.

Qualitative data will be analysed thematically according to Braun and Clarke’s method following these steps: (1) data familiarisation, (2) generating initial codes, (3) searching for themes, (4) reviewing themes, and (5) defining themes.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

15/07/2024

Date of last participant enrolment

Anticipated

30/06/2025

Actual

Date of last data collection

Anticipated

31/12/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC Medical Research Futures Fund - Dementia

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

The University of Queensland

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Queensland Human Research Ethics Committee A

Ethics committee address [1]

https://www.uq.edu.au/research/research-support/ethics-integrity-and-compliance/human-ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/11/2023

Approval date [1]

20/03/2024

Ethics approval number [1]

2023/HE002236

Summary

Brief summary

Our study is about helping older Australians with hearing and/or vision impairment stay in their own homes and communities as they age. We want to evaluate the impact of a hearing and vision support program that is aimed at improving quality of life, hearing and vision function, and overall well-being of home care recipients with hearing and/or vision impairment and their informal caregivers. We believe that the 3 month home-based sensory support program will help older adults with hearing and/or vision problems live better and do daily activities more easily.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Piers Dawes

Address

Building 84A Therapies, The University of Queensland, St Lucia, 4072, Queensland

Country

Australia

Phone

+61 7 3443 3769

Fax

[email protected]

Contact person for public queries

Name

Melinda Toomey

Address

Building 82C, The University of Queensland, St Lucia, 4072, Queensland

Country

Australia

Phone

+61 7 3443 6073

Fax

[email protected]

Contact person for scientific queries

Name

Melinda Toomey

Address

Building 82C, The University of Queensland, St Lucia, 4072, Queensland

Country

Australia

Phone

+61 7 3443 6073

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All de-identified individual line-by-line data

When will data be available (start and end dates)?

Immediately following publication, no end date determined

Available to whom?

Anyone who wishes to access it.

Available for what types of analyses?

Any purpose

How or where can data be obtained?

The de-identified line-by-line data will be archived in a publicly accessible repository (The University of Queensland Research Data Manager, UQRDM)
https://rdm.uq.edu.au/

What supporting documents are/will be available?

Doc. No.	Type	Attachment
24093	Study protocol	388247-(Uploaded-05-08-2024-15-15-47)-01_Home Care Phase 2 Protocol_v7_clean.docx
24094	Ethical approval	388247-(Uploaded-05-08-2024-15-16-33)-Decision notification letter_P2_V1.01_20.03.24.pdf
24095	Ethical approval	388247-(Uploaded-05-08-2024-15-17-02)-Decision notification letter_modification_24.05.14.pdf
24096	Ethical approval	388247-(Uploaded-05-08-2024-15-17-22)-HE002236_Approval_P2_v3.01_24.06.26.pdf
24097	Ethical approval	388247-(Uploaded-05-08-2024-15-17-48)-HE002236_Approval_P2_v4.01_24.07.31.pdf
24098	Informed consent form	388247-(Uploaded-08-08-2024-09-48-46)-App_D_Participant Info Sheet_P2_v4_clean_Implementation.pdf
24099	Informed consent form	388247-(Uploaded-08-08-2024-09-49-03)-App_E_consent forms_P2_V4_Implementation.pdf

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.

Trial Review

Documents added manually

Documents added automatically