Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000323628
Ethics application status
Approved
Date submitted
8/02/2023
Date registered
27/03/2023
Date last updated
13/10/2024
Date data sharing statement initially provided
27/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising support for Chinese carers of people with dementia by embedding iSupport in routine care services
Scientific title
Optimising support for Chinese carers of people with dementia by embedding iSupport in routine care services
Secondary ID [1] 308919 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 328922 0
Condition category
Condition code
Neurological 325913 325913 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a type 2 hybrid effectiveness-implementation randomised controlled trial to (1) determine the effectiveness of the ‘Tailored iSupport’ intervention for carers and people with dementia and (2) to evaluate the effectiveness of the implementation strategies applied to embed the ‘Tailored iSupport’ into the routine services of aged care organisations in real-world settings. The study will also explore the experiences of carers, frontline staff and facilitators in the project. The interventions in the study are outlined in the following:
Carers in the ‘Tailored iSupport’ group will be assigned to a trained facilitator, who is a health professional or social care professional with expertise in dementia care. The facilitators will undergo 3 x 2 hours online workshops over a 2-week period and the training sessions will be provided 6 weeks prior to initiation of the intervention. The training sessions will be relative to delivering the intervention including: 1) Introduction to the project; 2) being an effective facilitator and 3) recruitment, data collection and outcome measures used in the project. The CIs in the project will provide the training sessions. Moreover, facilitators will participate in a 30-minute online debrief and coaching session every 2 weeks with the CIs in the project during the intervention period to ensure their facilitation alights with the intended project outcomes and to help them with problem-solving skill development.
The facilitators will provide individualised support to carers by engaging them in: 1) relevant iSupport modules: The facilitator will assess carers’ individualised needs in the program in an individual meeting lasting 45-60 minutes 2 weeks prior to the intervention using the ‘Risk Appraisal Measure’ (Adapted from Czaja et al. 2009). The facilitator will recommend learning modules, for example ‘Module 5 Dealing with changed behaviours’ when the carer reports sudden/worrisome changes in care recipient’s memory and mood. 2) monthly peer support group meetings lasting about 30-45 minutes (online or face-to-face): The meeting will include up to 8 carers. 3) weekly text messages extracted from iSupport to target carers’ learning needs; 4) resources/services tailored to their needs: Carers are encouraged to make individual appointments with their facilitator to request assistance to access and utilise resources/services when their care recipients experience changes, for example in the case of sudden changes in behaviours, the facilitator will recommend GP visit to identify the causes or refer them to Dementia Support Australia (in Australia’s study sites only). Facilitators will maintain a portfolio to record all contact instances with carers throughout the intervention period. 5) The facilitators will provide monthly staff training on iSupport during the intervention period using the existing paid staff development time, provide practical support for frontline staff in the workplace regarding partnership with carers. The intervention will last 6 months.
Intervention code [1] 325362 0
Treatment: Other
Comparator / control treatment
Carers in the usual iSupport group will be supported by frontline staff introducing various iSupport resources (i.e., Web-based iSupport, iSupport audiobook, iSupport eBook or hardcopy) and providing them with an ‘Introduction to iSupport’ leaflet that details the access and utilisation of various iSupport resources. The iSupport resources listed will be available to all carers prior to the trial. The ‘Introduction to iSupport’ leaflet has been designed specifically for this study.
Control group
Active

Outcomes
Primary outcome [1] 333751 0
Carers’ mental health related quality of life (QoL) will be assessed as our primary outcome using the mental health related QoL items described in the 12-Item Short-Form Health Survey (SF-12).
Timepoint [1] 333751 0
The questionnaire will be completed at baseline, 3 months and 6 months post-initiation of the intervention. The primary timepoint is 6 months post-initiation of the intervention.
Secondary outcome [1] 418152 0
Carers‘ self-efficacy will be assessed using RIS Eldercare Self-Efficacy Scale. The scale measures self-efficacy for obtaining respite, responding to atypical patient behaviours and controlling upsetting thoughts about caregiving.
Timepoint [1] 418152 0
Baseline, 3 months and 6 months post-initiation of the intervention.
Secondary outcome [2] 418153 0
Carers‘ experiences in the ‘Tailored iSupport’ group will be assessed as our secondary outcome. Monthly peer support group meeting will be recorded and one-on-one interview with carers at 3 months and 6 months after the initiation of the intervention using an interview guide will be conducted to assess carers’ experiences.
Timepoint [2] 418153 0
3 months and 6 months post-initiation of the intervention.
Secondary outcome [3] 418154 0
The quality of life for people with dementia under the care of the study participants will be assessed using the 'Quality of Life in Alzheimer’s Disease (QOL-AD)-Proxy'.
Timepoint [3] 418154 0
Baseline, 3 months and 6 months post-initiation of the intervention.
Secondary outcome [4] 418158 0
Quality of care experience in community aged care perceived by people with dementia using the 'Quality of care experience (QCE) community aged care-proxy rating'.
Timepoint [4] 418158 0
Baseline, 3 months and 6 months post-initiation of the intervention.
Secondary outcome [5] 418163 0
Work environment adjustments required to embed iSupport will be recorded in the ‘Facilitator portfolio’ submitted to the project team and will be reported in the biweekly debrief meetings with facilitators.
Timepoint [5] 418163 0
Monthly for 6 months during the trial.
Secondary outcome [6] 418164 0
Time spent by facilitator on carer peer support meeting will be recorded by the facilitators in their portfolios.
Timepoint [6] 418164 0
Monthly for 6 months during the trial.
Secondary outcome [7] 418165 0
Time spent by facilitator on sending text messages to carers will be recorded by the facilitators in their portfolios..
Timepoint [7] 418165 0
Monthly for 6 months during the trial.
Secondary outcome [8] 418166 0
Time spent by facilitator on assisting carers to access and using resources will be recorded by the facilitators in their portfolios..
Timepoint [8] 418166 0
Monthly for 6 months during the trial.
Secondary outcome [9] 418167 0
Data on carer satisfaction with support they received from the iSupport facilitators will be collected through project audit survey that has been designed specifically for this trial.
Timepoint [9] 418167 0
3 months and 6 months post-initiation of the intervention.
Secondary outcome [10] 418168 0
Data on frontline staff satisfaction with support they receive from the iSupport facilitator will be collected through project audit survey that has been designed specifically for this trial. .
Timepoint [10] 418168 0
3 months and 6 months post-initiation of the intervention.
Secondary outcome [11] 418169 0
Data on the experiences of facilitators in the project will be collected using facilitator portfolio submitted to the project team and recorded online debrief sessions with peers and the project team.
Timepoint [11] 418169 0
Monthly for 6 months during the trial.
Secondary outcome [12] 418170 0
Data on the ways that the industry partners have embedded the ‘Usual iSupport’ and the ‘Tailored iSupport’ in routine care services of new sites will be collected using the organisations’ records.
Timepoint [12] 418170 0
6 months post-initiation of the intervention.
Secondary outcome [13] 418173 0
Evidence to show that 'the Tailored iSupport' is offered to carers after the trial will be collected using the organisations’ records.
Timepoint [13] 418173 0
6 months post-initiation of the intervention.
Secondary outcome [14] 418360 0
Self-reported unplanned hospital admissions of people with dementia in the trial by carers. The information will be verified by researcher in collaboration with the iSupport facilitators and frontline staff involved in the trial.
Timepoint [14] 418360 0
Baseline (data on 6 months prior to intervention), 3 months and 6 months post-initiation of the intervention.
Secondary outcome [15] 419795 0
The numbers of carers who completed or withdrawn from the 'Tailored iSupport' will be obtained from the survey data. The data will help the analysis of the reach and the implementation of the iSupport program.
Timepoint [15] 419795 0
Baseline, 3 months and 6 months post-initiation of the intervention.
Secondary outcome [16] 419796 0
Positive experience of frontline staff in the care of people with dementia and in working with their family carers will be collected during 2 focus groups with frontline staff engaged in iSupport delivery to carers.
Timepoint [16] 419796 0
3 months and 6 months post-initiation of the intervention.
Secondary outcome [17] 419797 0
Self-reported emergency department use of people with dementia in the trial by their carers. The information will be verified by researcher in collaboration with the iSupport facilitators and frontline staff involved in the trial.
Timepoint [17] 419797 0
Baseline (data on 6 months prior to intervention), 3 months and 6 months post-initiation of the intervention.
Secondary outcome [18] 419798 0
Self-reported permanent admissions to an aged care facility of people with dementia in the trial by their carers. The information will be verified by researcher in collaboration with the iSupport facilitators and frontline staff involved in the trial.
Timepoint [18] 419798 0
3 months and 6 months post-initiation of the intervention.

Eligibility
Key inclusion criteria
This study will be undertaken in aged care organisations in Australia and Community Health Centres (CHCs; primary care managed by general practitioners and registered nurses) in China. In Australia, participants will be recruited in community aged care settings managed by three Chinese ethno-specific aged care organisations based in Adelaide (South Australia) and Sydney (New South Wales). In China, participants will be recruited in 6 CHCs in Xian’s Shanxi Province and in Zunyi, Guizhou Province respectively. There are three participant categories, namely Chinese carers of people with dementia (PWD), frontline staff and iSupport facilitators, in the study.
Inclusion criteria for Chinese carers of people with dementia (PWD): aged 18 years or over; caring at least twice a week for an adult living with dementia. If a care recipient has no formal dementia diagnosis but meets cognitive impairment using the "AD8 Dementia Screening Interview" (Li et al. 2012). Exclusion criteria: carers have severe mental health conditions or terminal illness themselves; are involved in other studies or participated in the previous iSupport RCT trial.
Inclusion criteria for frontline staff: frontline staff involved in the care of PWD and the carers to the study will be invited to participate.
Inclusion criteria for iSupport facilitators: The iSupport facilitators will be appointed by their organisations through an internal selection process. They will be health care professionals or social care professionals with at least 2 years experiences in the care of people with dementia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for Chinese carers of people with dementia (PWD): (1) carers have severe mental health conditions or a terminal illness; (2) carers involve in other studies.
Exclusion criteria for Chinese carers of frontline staff: agency staff.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment is ensured by:
1. Participants will be assigned a code by research assistant
2. The biostatistician who has no contact with participants will randomly assign code into groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After baseline data collection, carers will be randomly assigned to receive either the tailored iSupport or the usual iSupport. To ensure the two groups are of equivalent size, a randomly generated block size of 4 will be used to allocate carers to one of the two treatment groups for each recruitment site. An independent clinical trial management centre will provide randomisation services to the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data will be analysed on an intention-to-treat basis based on group assignments. A multivariate mixed effect linear regression model will be applied to fit linear mixed models and to examine the primary and secondary outcomes between groups. As the outcome occurs for each individual with repeated time points, the mixed effect models will capture both fixed effects and random effects within the hierarchical structure of the data. The fixed effects, including group effect, time effect and group x time interaction, will be analogous to the regression coefficients. The random effects represent the estimated variability in the intercept to account for repeated measurements. The model will be adjusted by the baseline measure of outcome variable. The maximum likelihood estimate procedure will be used to compare significant differences in primary and secondary outcomes over time and between groups. Univariate models will be first used, then multivariate modelling will be undertaken by adding variables considered clinically important or statistically significant from the univariate model to adjust for confounding effects between variables. A series of models will be undertaken by adding and subtracting variables, with changes in model fit assessed by log likelihood to choose the final multivariate model. The two-sided test will be performed for all analyses and the level of significance will be set at p <0.05. All analyses will be performed using Stata software version 16.1. A Research Assistant, who will be blinded to group assignments, will undertake data analysis and will be supervised by Associate Professor Ullah, a biostatistician.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/05/2023
Actual
22/05/2023
Date of last participant enrolment
Anticipated
15/10/2024
Actual
Date of last data collection
Anticipated
15/04/2025
Actual
Sample size
Target
250
Accrual to date
258
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment outside Australia
Country [1] 25331 0
China
State/province [1] 25331 0
Shanxi Province
Country [2] 25332 0
China
State/province [2] 25332 0
Guizhou Province

Funding & Sponsors
Funding source category [1] 313129 0
Charities/Societies/Foundations
Name [1] 313129 0
Aged Care Research & Industry Innovation Australia (ARIIA) Grant
Country [1] 313129 0
Australia
Funding source category [2] 313432 0
Government body
Name [2] 313432 0
National Foundation for Australia- China Relation (NFACR), Australian Government
Country [2] 313432 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Australian Nursing Home Foundation
Address
60 Weldon Street,
Burwood NSW 2134
Country
Australia
Secondary sponsor category [1] 314830 0
Commercial sector/Industry
Name [1] 314830 0
Chinese Australian Services Society
Address [1] 314830 0
44-50 Sixth Ave, Campsie NSW 2194
Country [1] 314830 0
Australia
Secondary sponsor category [2] 314832 0
Commercial sector/Industry
Name [2] 314832 0
Chinese Welfare Services of SA
Address [2] 314832 0
222 Grote St, Adelaide SA 5000
Country [2] 314832 0
Australia
Other collaborator category [1] 282588 0
University
Name [1] 282588 0
School of Nursing, Xi’an Jiaotong University, China
Address [1] 282588 0
Xi'an Jiaotong University, No.28, Xianning West Road, Xi'an, Shaanxi, P.R. China, 710049
Country [1] 282588 0
China
Other collaborator category [2] 282589 0
University
Name [2] 282589 0
School of Nursing, Zunyi Medical University, China
Address [2] 282589 0
School of Nursing, Zunyi Medical University, 149 Dalian Road, Huichuan Distirct, Zunyi, Guizhou Province, P. R. China, 563003
Country [2] 282589 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312374 0
Human Research Ethics Committee, Flinders University
Ethics committee address [1] 312374 0
Ethics committee country [1] 312374 0
Australia
Date submitted for ethics approval [1] 312374 0
Approval date [1] 312374 0
05/12/2022
Ethics approval number [1] 312374 0
5819

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

Contacts
Principal investigator
Name 124430 0
Prof Lily Xiao
Address 124430 0
College of Nursing and Health Sciences
Flinders University
Sturt Road, Bedford Park
5042 GPO Box 2100
Adelaide SA
Country 124430 0
Australia
Phone 124430 0
+61 8 82013419
Fax 124430 0
+61 8 82761602
Email 124430 0
[email protected]
Contact person for public queries
Name 124431 0
Lily Xiao
Address 124431 0
College of Nursing and Health Sciences
Flinders University
Sturt Road, Bedford Park
5042 GPO Box 2100
Adelaide SA
Country 124431 0
Australia
Phone 124431 0
+61 8 82013419
Fax 124431 0
+61 8 82761602
Email 124431 0
[email protected]
Contact person for scientific queries
Name 124432 0
Lily Xiao
Address 124432 0
College of Nursing and Health Sciences
Flinders University
Sturt Road, Bedford Park
5042 GPO Box 2100
Adelaide SA
Country 124432 0
Australia
Phone 124432 0
+61 8 82013419
Fax 124432 0
+61 8 82761602
Email 124432 0
[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?
De-identified data related to the outcome measures published from this study will be shared.
When will data be available (start and end dates)?
Start date: Immediately after the outcomes from this study has been published in the peer review journals.
End dates: not applicable.
Available to whom?
Available to researchers for academic use.
Available for what types of analyses?
Systematic review and meta-analysis.
How or where can data be obtained?
Please contact the principal investigator in this project. The contact details for the principal investigator is listed in the following:
Professor Lily Xiao
Email: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18248Ethical approval    385343-(Uploaded-13-06-2023-16-27-56)-Study-related document.pdf



Results publications and other study-related documents

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