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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] 312686 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hearing impairment 334675 0
vision impairment 334676 0
cognition 334677 0
Mental well-being 334678 0
Condition category
Condition code
Ear 331247 331247 0 0
Other ear disorders
Eye 331248 331248 0 0
Diseases / disorders of the eye
Neurological 331249 331249 0 0
Dementias
Mental Health 331250 331250 0 0
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] 329213 0
Rehabilitation
Intervention code [2] 329214 0
Lifestyle
Intervention code [3] 329419 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339023 0
Health-related Quality of Life of older adults with hearing and/or vision impairment
Timepoint [1] 339023 0
Baseline, 13 weeks (primary timepoint) and 26 weeks post commencement
Primary outcome [2] 339025 0
Aged Care Consumer Quality of Life of older adults with hearing and/or vision impairment
Timepoint [2] 339025 0
Baseline, 13 weeks (primary timepoint) and 26 weeks post commencement
Primary outcome [3] 339026 0
Health Resources Used for informal caregivers
Timepoint [3] 339026 0
Baseline, 13 weeks (primary time point) and 26 weeks post commencement
Secondary outcome [1] 438290 0
Health Related Quality of Life of Informal Caregivers (primary outcome) for informal caregivers
Timepoint [1] 438290 0
Baseline, 13 weeks and 26 weeks post commencement
Secondary outcome [2] 438291 0
Social care-related quality of life (older adults with hearing and/or vision impairment) for older adults with hearing/vision impairment
Timepoint [2] 438291 0
Baseline, 13 weeks and 26 weeks post commencement
Secondary outcome [3] 438292 0
Activities of Daily Living (older adults with hearing and/or vision impairment)
Timepoint [3] 438292 0
Baseline, 13 weeks and 26 weeks post commencement
Secondary outcome [4] 438293 0
Hearing Function (older adults with hearing and/or vision impairment)
Timepoint [4] 438293 0
Baseline, 13 weeks and 26 weeks post commencement
Secondary outcome [5] 438294 0
Cognitive Function for older adults with hearing/vision impairment
Timepoint [5] 438294 0
Baseline, 13 week, and 26 weeks post commencement
Secondary outcome [6] 438295 0
Visual Function (older adults with hearing and/or vision impairment)
Timepoint [6] 438295 0
Baseline, 13 weeks and 26 weeks post commencement
Secondary outcome [7] 438296 0
Anxiety (older adults with hearing/vision impairment)
Timepoint [7] 438296 0
Baseline, 13 weeks and 26 weeks post commencement
Secondary outcome [8] 438297 0
Depression (older adults with hearing and/or vision impairment)
Timepoint [8] 438297 0
Baseline, 13 weeks and 26 weeks post commencement
Secondary outcome [9] 438298 0
Dementia Symptoms (older adults with hearing and/or vision impairment)
Timepoint [9] 438298 0
Baseline, 13 weeks and 26 weeks post commencement
Secondary outcome [10] 438299 0
Quality and quantity of Social Interactions (older adults with hearing and/or vision impairment) This will be assessed as a composite outcome.
Timepoint [10] 438299 0
Baseline, 13 weeks and 26 weeks post commencement
Secondary outcome [11] 438300 0
Quality of Relationship (Informal caregivers)
Timepoint [11] 438300 0
Baseline, 13 weeks and 26 weeks post commencement
Secondary outcome [12] 438301 0
Third-party hearing loss-related quality of life (informal caregiver)
Timepoint [12] 438301 0
Baseline, 13 weeks and 26 weeks post commencement
Secondary outcome [13] 438305 0
Implementation Outcome - Feasibility
Timepoint [13] 438305 0
At the end of each sensory support program session
Secondary outcome [14] 438306 0
Implementation Outcome - Appropriateness
Timepoint [14] 438306 0
At the end of each sensory support program session
Secondary outcome [15] 438307 0
Implementation Outcome - Fidelity
Timepoint [15] 438307 0
At the end of each sensory support program session
Secondary outcome [16] 438308 0
Implementation Outcome - Acceptability
Timepoint [16] 438308 0
At the end of each sensory support program session
Secondary outcome [17] 438309 0
Implementation Outcome - Contextual Issues
Timepoint [17] 438309 0
Interviews will be conducted between week 10 to week 26 depending on participant availability.
Secondary outcome [18] 439830 0
Cognitive function (informal caregivers)
Timepoint [18] 439830 0
Baseline, 13 weeks and 26 weeks post intervention commencement
Secondary outcome [19] 439831 0
Anxiety (informal caregivers)
Timepoint [19] 439831 0
Baseline, 13 weeks and 26 weeks post-intervention commencement
Secondary outcome [20] 439832 0
Depression (informal caregivers)
Timepoint [20] 439832 0
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?
No
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
87
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317118 0
Government body
Name [1] 317118 0
NHMRC Medical Research Futures Fund - Dementia
Country [1] 317118 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 319380 0
None
Name [1] 319380 0
Address [1] 319380 0
Country [1] 319380 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315872 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 315872 0
Ethics committee country [1] 315872 0
Australia
Date submitted for ethics approval [1] 315872 0
20/11/2023
Approval date [1] 315872 0
20/03/2024
Ethics approval number [1] 315872 0
2023/HE002236

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136046 0
Prof Piers Dawes
Address 136046 0
Building 84A Therapies, The University of Queensland, St Lucia, 4072, Queensland
Country 136046 0
Australia
Phone 136046 0
+61 7 3443 3769
Fax 136046 0
Email 136046 0
p.dawes@uq.edu.au
Contact person for public queries
Name 136047 0
Melinda Toomey
Address 136047 0
Building 82C, The University of Queensland, St Lucia, 4072, Queensland
Country 136047 0
Australia
Phone 136047 0
+61 7 3443 6073
Fax 136047 0
Email 136047 0
m.toomey@uq.edu.au
Contact person for scientific queries
Name 136048 0
Melinda Toomey
Address 136048 0
Building 82C, The University of Queensland, St Lucia, 4072, Queensland
Country 136048 0
Australia
Phone 136048 0
+61 7 3443 6073
Fax 136048 0
Email 136048 0
m.toomey@uq.edu.au

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.TypeCitationLinkEmailOther DetailsAttachment
24093Study protocol    388247-(Uploaded-05-08-2024-15-15-47)-01_Home Care Phase 2 Protocol_v7_clean.docx
24094Ethical approval    388247-(Uploaded-05-08-2024-15-16-33)-Decision notification letter_P2_V1.01_20.03.24.pdf
24095Ethical approval    388247-(Uploaded-05-08-2024-15-17-02)-Decision notification letter_modification_24.05.14.pdf
24096Ethical approval    388247-(Uploaded-05-08-2024-15-17-22)-HE002236_Approval_P2_v3.01_24.06.26.pdf
24097Ethical approval    388247-(Uploaded-05-08-2024-15-17-48)-HE002236_Approval_P2_v4.01_24.07.31.pdf
24098Informed consent form    388247-(Uploaded-08-08-2024-09-48-46)-App_D_Participant Info Sheet_P2_v4_clean_Implementation.pdf
24099Informed 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

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