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Trial registered on ANZCTR


Registration number
ACTRN12625000245493
Ethics application status
Approved
Date submitted
3/02/2025
Date registered
4/04/2025
Date last updated
4/04/2025
Date data sharing statement initially provided
4/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Novel co-designed service to support health and wellbeing of older carers of older people: A study protocol.
Scientific title
A study protocol for a pragmatic pre-post trial to determine the feasibility and effectiveness of a novel co-designed service to support health and wellbeing of older carers of older people.
Secondary ID [1] 311544 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
carer burden 332900 0
depression 332901 0
anxiety 332902 0
impaired physical health 332903 0
impaired function 332904 0
fatigue 336385 0
sleep disturbances 336386 0
Condition category
Condition code
Mental Health 332755 332755 0 0
Anxiety
Mental Health 332756 332756 0 0
Depression
Physical Medicine / Rehabilitation 332757 332757 0 0
Physiotherapy
Physical Medicine / Rehabilitation 332758 332758 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Older carers will attend a multidisciplinary Carer Health and Wellbeing Service (CHWS) - the intervention - which is staffed by a social worker, psychologist, physiotherapist and occupational therapist. Interventions will be tailored to the carers' self-prioritised needs, based on an initial screening tool (the Carer Support Needs Assessment Tool (CSNAT). Interventions will be determined to address the prioritised health and wellbeing needs of the carer. Interventions may be delivered by the CHWS staff, or if not available through the Service staff, will be referred to external service providers (for example for management of a carer prioritised need by health professionals not involved in the Service, e.g. dietitian; podiatrist; sleep disorders clinic). An episode of care for carers will be 6 months, although this may be extended if required by some carers. The service is operating at one of the Peninsula Health sites (Frankston, Victoria, Australia).

Interventions will be determined through shared decision-making between the carer and their primary contact CHWS staff member and will be informed by the carer-prioritised needs (CSNAT and other needs), and assessment findings. Depending on the areas of expertise and capacity of CHWS staff relative to the prioritised carer needs, some interventions will be delivered by CHWS staff, while other interventions may require referral to other practitioners or services, within or external to Peninsula Health. Carers will be encouraged to continue other health and wellbeing strategies they may be undertaking at the time of attending the CHWS.

INTERVENTIONS PROVIDED BY THE CHWS OR REFERRALS TO OTHER PRACTITIONERS OR SERVICES
Following intake assessments at the CHWS, an initial individualised intervention plan will be developed with the carer. This plan will be reviewed regularly to ensure interventions are adapted if necessary to meet changing needs. Interventions will be individualised to the carer and may be changed over time through ongoing shared decision-making between the carer and the CHWS staff, depending on progress and possibly changing needs. The CHWS staff will follow up with the carer to support implementation of one or more intervention options that are within their scope of practice to deliver, through provision of information or resources, through direct intervention provision (e.g. if the Primary Contact is a physiotherapist, and the carer has strength or fitness needs, they may be provided with a tailored home exercise program or participate in a CHWS-based group exercise program), or through other actions as required.
There will be broad flexibility in the type and nature of intervention/s that will be initiated in the first instance, including whether the intervention is delivered by CHWS staff, whether it involves referral to an external service/provider/practitioner, and its mode of delivery (face-to-face, online, or hybrid). If assessments indicate the need for medical review for the carer, they will be informed of this, and with their consent, provided with a letter to their medical practitioner outlining assessment findings, planned interventions, and reasons for recommending a medical review.
One or more intervention options will be determined through shared decision making between the carer and the clinican to address one or more of the carer prioritised needs from the CSNAT. Possible options for interventions could include the following (although this is not an exhaustive list):
- Social Worker - counselling, group sessions, advocacy, sessions focused on navigating changing relationships or care planning.
- Clinical Psychologist - psychoeducation, cognitive behavioural therapy, grief counselling, and sessions focused on interventions related to symptoms of anxiety and/or depression.
- Occupational Therapist - relaxation, mindfulness and stress management techniques, energy conservation techniques, sleep management strategies, manual handling training and assistive technology to support the carer at home.
- Physiotherapist - exercise programs (including tailored home-based, group-based, supervised 1:1 sessions, or other as needed), physical activity advice and support, manual handling training, and mobility/gait aid as needed.

OTHER INTERVENTIONS PROVIDED THROUGH THE CWHS (IN ADDITION TO THOSE OUTLINED ABOVE):
Staff will have a range of publicly available information resources to provide to carers, or for carers to search through a structured online portal. While much of the information resources will be focused on carer health and wellbeing, some are also related to improving the carers’ understanding of the care recipient’s specific health condition/s, possible prognosis, and what to expect and prepare for. Where indicated, carers may be referred to their or their care recipient’s medical practitioner for further details of the care recipient’s status and prognosis.
The CHWS staff will run intermittent education sessions to support carers (may be online, face-to-face, or hybrid; initial aim to run these each 3 months), and/or link carers to other existing programs available within the community/other organisations, to address commonly identified issues that may benefit from a group education approach. Opportunities for carer peer support (through face-to-face or online) will be provided.

MONITORING INTERVENTION ACTIVITY AND ADHERENCE
During or after each session with a participant, staff will document interventions provided, self-reported adherence to interventions, factors influencing limited adherence, and any changes to improve adherence by participants.

CHWS STAFF TEAM DISCUSSION AND COMMUNICATION WITH MEDICAL PRACTITIONERS AND OTHER SERVICE PROVIDERS:
After a carer’s initial appointment or after their 6 month (end of episode of care) assessment, and at other times as required, the CHWS team will meet to discuss identified needs, intervention plan, outcome/s and other relevant issues. On these occasions, a letter from the CHWS Primary staff contact will be sent to the carer’s general practitioner (or other service provider, as recommended by the carer) outlining the CHWS staff assessment findings, intervention plan/s, and after the 6 month assessment – outcomes of the intervention and ongoing plans.

SUBSEQUENT APPOINTMENTS AND EPISODE OF CARE:
CHWS staff may schedule face-to-face, phone or online appointments with carers to follow up on aspects of interventions or activities after the first appointment, at a frequency and duration that is mutually agreed upon between the carer and the staff member (frequency and duration will be documented).
Carer involvement with the CHWS will last an average of 6 months (episode of care), from initial contact to final assessment, with a standard episode of care being six months duration, from the time of completion of the initial assessments. The decision regarding discharge timing will be made by the CHWS Primary contact staff member and the carer.
Although it is anticipated that the standard episode of care will be six months, carers with ongoing needs being actively addressed by the CHWS or who have added one or more extra interventions during the 6 month period may opt to continue with the Service beyond the 6 month mark. In these cases, the six month assessment will be undertaken as planned; and a discharge assessment will take place when later discharge occurs. Those who complete an episode of care with the CHWS can be re-referred if their circumstances change, or new issues arise.
For situations where the person being cared for transitions from home to residential care (for permanent care, not for respite care), or in situations where a care-recipient passes away during the episode of care for the carer, the carer will have the option to continue with CHWS support (with review to determine if needs have changed), or to cease involvement with the CHWS (with re-assessment at this time point if this is acceptable to the carer).
Intervention code [1] 330251 0
Behaviour
Intervention code [2] 330252 0
Rehabilitation
Intervention code [3] 330253 0
Lifestyle
Comparator / control treatment
This is a pre-post mixed methods design study. Participants will be assessed at time of commencement of attendance at the Carer Health and Wellbeing Service, and at 6 months follow-up.
No control group will be used.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340389 0
Caregiver self-report of preparedness for caregiving
Timepoint [1] 340389 0
Baseline; and 6 months post commencement of intervention
Primary outcome [2] 340390 0
Reach (implementation primary outcome)
Timepoint [2] 340390 0
For the duration of recruitment (March 2024 - end of May 2025)
Primary outcome [3] 340391 0
Adoption (implementation primary outcome)
Timepoint [3] 340391 0
For the duration of carer interventions (March 2024 - end of Nov 2025)
Secondary outcome [1] 443933 0
Quality of Life.
Timepoint [1] 443933 0
Baseline and 6 months post commencement of intervention
Secondary outcome [2] 443934 0
Caregiver self-report of preparedness for caregiving
Timepoint [2] 443934 0
Baseline and 6 months post commencement of intervention
Secondary outcome [3] 443935 0
Cost effectiveness
Timepoint [3] 443935 0
Baseline and 6 months post commencement of intervention
Secondary outcome [4] 443936 0
Program fidelity (implementation outcome)
Timepoint [4] 443936 0
Will assess full episode of care for selected carers (baseline to six months)
Secondary outcome [5] 443937 0
Adaptations (implementation ouctome)
Timepoint [5] 443937 0
Across the duration of the Carer Health and Wellbeing Service operations (March 2024-Nov 2025)
Secondary outcome [6] 443938 0
Maintenance (at the individual carer level) (implementation outcome)
Timepoint [6] 443938 0
6 months post commencement of intervention. This data will be collected from the participant electronic medical record data.
Secondary outcome [7] 444061 0
Acceptability of the intervention (carer perspectives)
Timepoint [7] 444061 0
After the assessment 6 months post commencement of the intervention.
Secondary outcome [8] 445050 0
Acceptability of the intervention (referrer perspectives)
Timepoint [8] 445050 0
In the last 6 months of the program valuation (May - November 2025)
Secondary outcome [9] 445051 0
Acceptability of the intervention (staff perspectives)
Timepoint [9] 445051 0
In the last 6 months of the program valuation (May - November 2025)

Eligibility
Key inclusion criteria
There are three participant groups for this study:
1. Carers, defined as “family members and/or friends who routinely support the older person through assistance with household tasks; self-care and mobility; emotional and social support; treatments, medication and responding to acute health needs; advocacy and care coordination; or surrogate decision-making”. The inclusion criteria for carers attending the CHWS, and for this study are (a) being aged 50 years or older; (b) living in the community; and (c) being an informal (unpaid) carer (as defined above) for a person aged >65 years living in the community; and they provide informed consent to participate in the research..
2. Referrers, who refer carers to the Carer Health and Wellbeing Service. Inclusion criteria for referrers are that they have referred two or more carers to the Service, and that they provide informed consent for the semi-structured interview component of the research. NOTE - The minimum age of referrers is 18 years
3. Staff of the Carer Health and Wellbeing Service. Inclusion criteria are being a staff member of the Carer Health and Wellbeing Service, and providing informed consent for the semi-structured interview component of the study. NOTE: The minimum age for staff is 18 years.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
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
This is a pragmatic evaluation study of a new service at Peninsula Health, which will recruit for a 15 month period, with six month follow-up assessments. In the first 10 months of operation, the CHWS will operate one day/week, and for the subsequent five months, two days/week (to allow time for growth in referral base). Conservatively, we estimate two new referrals / week on average for the first 5 months of CHWS operations, 4/week for months 6-10, and then for the final five months of recruitment (with the CHWS operating 2 days/week) 8 referrals/week. Based on 48 weeks/year of operation, over the 1.25 years of recruitment for the study, this will mean an anticipated 248 people referred. We estimate that 55% of carers referred to attend the Service will consent to participating in the project (n=137) and undergo assessment and intervention. A previous intervention study to support carers of older people being discharged home from hospital achieved a significant mean improvement of 0.2 on the total average item score for the primary effectiveness outcome measure – the Preparedness for Caregiving Scale (34) (mean average item score at baseline = 2.67 (0.57 sd) on the 0-4 scale for each item, with a sample of n=140 (two groups). This sample size is expected to be sufficient for the majority of effectiveness and implementation outcome measures being collected.

The sample size for the referrer participants (for the semi-structured interviews) is 20-25 (to data saturation).; and for the staff participants (for semi-structured interviews) is 4.

Data analysis
Extracted data for the CHWS evaluation comparing baseline and 6 month assessment data will be analysed using parametric analyses for continuous, normally distributed data, and non-parametric analyses for categorical or non-normally distributed data. Analyses for comparison of the continuous core and additional domain assessment between initial and 6 month assessments will be performed using generalised linear regression. Analyses will be conducted on an intention-to-treat basis.
Analysis for the cost effectiveness evaluation will involve the costing of items based on actual costs where available, and where these are not available, costs, excluding carer time, will be based on market rates, with carer time based on the minimum wage. All costs will be presented as AUD 2025/26, with costs collected prior to 2025/26 to be inflated by CPI. The EQ-5D-5L raw scores will be converted to a utility index using Australian weights, and then into QALYs. The ICER will be calculated using the bootstrap method (5,000 replications) with the results presented on a cost-effectiveness plane and as a probability of cost-effectiveness across a range of willingness to pay thresholds (AUD $0 to $50,000).
For the qualitative study (semi-structured interviews) of carers and referrers, recruitment will continue until data saturation for the carers and the referrers groups. Thematic analyses will be undertaken independently by two members of the research team for each participant group, using Braun and Clarke’s six stages of reflexive thematic analysis. In cases of disagreement between the coders, the two team members will discuss their perspectives to achieve agreement on themes. The thematic analyses will then be presented to a subgroup of the research team and the CHWS staff (n=6) to review and discuss themes, for finalisation of the thematic analysis for each participant group. Commonalities and differences in themes between the participant groups will be identified. All quotes to support themes will be de-identified.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/03/2024
Date of last participant enrolment
Anticipated
30/05/2025
Actual
Date of last data collection
Anticipated
28/11/2025
Actual
Sample size
Target
137
Accrual to date
60
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315841 0
Government body
Name [1] 315841 0
The Commonwealth Government of Australia through the Community Health and Hospitals Program Grant Scheme.
Country [1] 315841 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 317969 0
Hospital
Name [1] 317969 0
Peninsula Health
Address [1] 317969 0
Country [1] 317969 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314696 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [1] 314696 0
Ethics committee country [1] 314696 0
Australia
Date submitted for ethics approval [1] 314696 0
15/05/2023
Approval date [1] 314696 0
22/09/2023
Ethics approval number [1] 314696 0
LNR99736PH-2023
Ethics committee name [2] 316844 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 316844 0
Ethics committee country [2] 316844 0
Australia
Date submitted for ethics approval [2] 316844 0
16/10/2023
Approval date [2] 316844 0
07/11/2023
Ethics approval number [2] 316844 0
40977

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

Contacts
Principal investigator
Name 132426 0
Dr Aislinn Lalor
Address 132426 0
Rehabilitation Ageing and Independent Living (RAIL) Research Centre, Monash University (Peninsula Campus), 47 - 49 Moorooduc Hwy, Frankston, Victoria, 3199
Country 132426 0
Australia
Phone 132426 0
+61 3 9904 4412
Fax 132426 0
Email 132426 0
[email protected]
Contact person for public queries
Name 132427 0
Aislinn Lalor
Address 132427 0
Rehabilitation Ageing and Independent Living (RAIL) Research Centre, Monash University (Peninsula Campus), 47 - 49 Moorooduc Hwy, Frankston, Victoria, 3199
Country 132427 0
Australia
Phone 132427 0
+61 3 9904 4412
Fax 132427 0
Email 132427 0
[email protected]
Contact person for scientific queries
Name 132428 0
Aislinn Lalor
Address 132428 0
Rehabilitation Ageing and Independent Living (RAIL) Research Centre, Monash University (Peninsula Campus), 47 - 49 Moorooduc Hwy, Frankston, Victoria, 3199
Country 132428 0
Australia
Phone 132428 0
+61 3 9904 4412
Fax 132428 0
Email 132428 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


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.