Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000246583
Ethics application status
Approved
Date submitted
10/01/2024
Date registered
13/03/2024
Date last updated
13/03/2024
Date data sharing statement initially provided
13/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Developing, implementing, and evaluating the 3C Program for residential respite care seekers and their carers
Scientific title
Developing, implementing, and evaluating the 3C Program for residential respite care seekers and their carers
Secondary ID [1] 311221 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 332436 0
Cognitive Impairment 332690 0
Carer well-being 332691 0
Condition category
Condition code
Public Health 329128 329128 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Whilst not strictly an intervention study in the conventional sense, the project possesses similar qualities. One component of this research project is the implementation of the 3C program. The 3C program is a novel method of assisting the handover of care from the community to residential respite. It involves the undertaking of a comprehensive geriatric assessment (CGA) by a health professional (likely a nurse), which will identify areas of health risk or concern and clinical referrals will be made where necessary. Following this, a care plan will be developed and personalised video vignettes produced, which will be handed over to Residential Aged Care Facility (RACF) staff where a participant is accessing residential respite. Care staff will be trained on how to read and access the 3C Program materials. The research team will not be involved with the provision of care once handover of materials has occurred. RACF staff will provide care to participants in accordance with their standard day-to-day care practices, while referring to the 3C Program resources as needed. Standard day-to-day care is defined as RACFs providing the care they would be providing to any individuals accessing residential respite regardless of whether they are participating in the 3C Program or not.

Participants in this project will complete a CGA, and they will be video recorded for the video vignettes. They will also answer some follow up questions after their respite stay has concluded.

Adherence and fidelity of RACF staff to the intervention (i.e. referring to and using the 3C Program materials) will not be assessed or monitored during the program implementation but will be collected during the evaluation phase when staff feedback about the 3C Program process and implementation will be collected.

Staff will be encouraged to read the care plans and watch the video vignettes for each participant at the start of their residential respite stay. Video vignettes may also be used for reference throughout the participant's respite stay. As we are examining the feasibility of using these video vignettes (and the wider 3C Program) in residential respite care, it is ultimately up to RACF staff to decide when and where it is appropriate to reference them. However, we will encourage staff to consult the video vignettes for a range of purposes. These purposes may include: understanding how to best manage distress or neuropsychiatric symptoms, identifying specific risks and negotiating strategies to minimise them, gaining an understanding of the respite-seeker's personality/likes/interests in order to best carry out day-to-day interactions with them.
Intervention code [1] 327679 0
Treatment: Other
Intervention code [2] 327856 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336948 0
Subjective ratings of the residential respite care
experience following 3C participation and respite admission (Composite outcome)
Timepoint [1] 336948 0
The outcome will be assessed first immediately following discharge or conclusion of respite care
The outcome will be assessed a second time at a point occurring up to 6 months following discharge or conclusion of respite care
Primary outcome [2] 336964 0
Likelihood of accessing residential respite again
Timepoint [2] 336964 0
The outcome will be assessed first immediately following discharge or conclusion of respite care
The outcome will be assessed a second time at a point occurring up to 6 months following discharge or conclusion of respite care
Primary outcome [3] 337480 0
Health-related quality of life for respite-seekers
Timepoint [3] 337480 0
The outcome will first be assessed before admission during the Comprehensive Geriatric Assessment
The outcome will be assessed a second time at a point occurring up to 6 months following discharge or conclusion of respite care
Secondary outcome [1] 430236 0
Quality of life for respite seekers before and following 3C participation and respite admission
Timepoint [1] 430236 0
The outcome will first be assessed before admission during the Comprehensive Geriatric Assessment
The outcome will be assessed a second time at a point occurring up to 6 months following discharge or conclusion of respite care
Secondary outcome [2] 430262 0
Clinical measures collected as part of the Comprehensive Geriatric Assessment (Composite Outcome)
Timepoint [2] 430262 0
The outcome will first be assessed before admission during the Comprehensive Geriatric Assessment
Some of the assessments may be repeated towards the end of, or immediately following discharge or conclusion of respite care
Secondary outcome [3] 430263 0
Number of adverse events experienced by recipients of the 3C Program during their respite admission. Adverse events may include: death, hospitalisation, falls and abscondment,
Timepoint [3] 430263 0
Single point Immediately following discharge or conclusion of respite care
Secondary outcome [4] 430509 0
RACF Staff feedback on the process of implementing the 3C Program
Timepoint [4] 430509 0
Single point following implementation of 3C program at employing RACF when feasible
Secondary outcome [5] 431117 0
Quality of life for carers before and following 3C participation and respite admission
Timepoint [5] 431117 0
The outcome will first be assessed before admission during the Comprehensive Geriatric Assessment
The outcome will be assessed a second time at a point occurring up to 6 months following discharge or conclusion of respite care
Secondary outcome [6] 431118 0
Carer burden before and following 3C participation and respite admission
Timepoint [6] 431118 0
The outcome will first be assessed before admission during the Comprehensive Geriatric Assessment
The outcome will be assessed a second time at a point occurring up to 6 months following discharge or conclusion of respite care
Secondary outcome [7] 431119 0
Number of care plans and Advanced Care Plans developed for recipients of the 3C Program during their respite admission
Timepoint [7] 431119 0
Single point immediately following discharge or conclusion of respite care

Eligibility
Key inclusion criteria
Participants must be over 18 years of age. Dyads will consist of a person accessing
residential respite and their informal carer.
All participants must be accessing respite care from, be the carer of someone accessing
residential respite, or be employed by, a Victorian RACF. Participants will not be excluded if
they do not have the capacity to provide informed consent; consent by proxy may be
provided by their carer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will not be excluded on the basis of English language proficiency. However, the research project will be conducted in English without the
availability of certified translators. Therefore individuals (or their medical decision maker)
who lack the ability to provide informed consent based on their English language proficiency or cannot meaningfully engage with the research project will be excluded.
There are no other exclusion criteria for participation aside from not meeting the inclusion
criteria, or what is described in the above paragraph.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
1/04/2025
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315480 0
Government body
Name [1] 315480 0
Australian Government Department of Health and Aged Care
Country [1] 315480 0
Australia
Primary sponsor type
Other Collaborative groups
Name
National Ageing Research Institute
Address
Building 8/34-54 Poplar Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 317554 0
Hospital
Name [1] 317554 0
Austin Health
Address [1] 317554 0
145 Studley Rd, Heidelberg VIC 3084
Country [1] 317554 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314389 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 314389 0
Ethics committee country [1] 314389 0
Australia
Date submitted for ethics approval [1] 314389 0
13/11/2023
Approval date [1] 314389 0
07/12/2023
Ethics approval number [1] 314389 0
HREC/103570/Austin-2023

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

Contacts
Principal investigator
Name 131406 0
A/Prof Frances Batchelor
Address 131406 0
National Ageing Research Institute, Building 8/34-54 Poplar Rd, Parkville VIC 3052
Country 131406 0
Australia
Phone 131406 0
+61 03 8387 2383
Fax 131406 0
Email 131406 0
[email protected]
Contact person for public queries
Name 131407 0
Dr. Christa Dang
Address 131407 0
National Ageing Research Institute, Building 8/34-54 Poplar Rd, Parkville VIC 3052
Country 131407 0
Australia
Phone 131407 0
+61 03 8387 2330
Fax 131407 0
Email 131407 0
[email protected]
Contact person for scientific queries
Name 131408 0
Dr. Christa Dang
Address 131408 0
National Ageing Research Institute, Building 8/34-54 Poplar Rd, Parkville VIC 3052
Country 131408 0
Australia
Phone 131408 0
+61 03 8387 2330
Fax 131408 0
Email 131408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.