Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000276853
Ethics application status
Approved
Date submitted
11/12/2020
Date registered
12/03/2021
Date last updated
7/10/2023
Date data sharing statement initially provided
12/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The evaluation of the Chinese iSupport for dementia program for caregivers in Australia and Greater China
Scientific title
A multicenter randomised controlled trial on effectiveness and cost-effectiveness of Chinese iSupport for dementia program in Australia and Greater China for caregivers in Australia and Greater China
Secondary ID [1] 302954 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 319982 0
Condition category
Condition code
Neurological 317918 317918 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of intervention(s) / exposure: The World Health Organization (WHO) has developed iSupport for Dementia, an online education program for informal carers, to enhance the public health response to dementia. Online dementia education programs have showed improved self-efficacy for carers, reduced dementia-related symptoms for care recipients and improved quality of life for both carers and the care recipients. The project team has translated the iSupport into Chinese and tested its feasibility in a pilot study in mainland China. The Chinese iSupport program has had a virtual carer support to enhance social support for carers. The aims of this multicenter randomised controlled trial are to (1) determine iSupport program effectiveness, and (2) establish iSupport program cost-effectiveness in Chinese caregivers in Australia and Greater China including Mainland China (Beijing and Xi'an), Taiwan, Hong Kong, Macau. In total, 204 caregivers will be randomly assigned to either an iSupport group (102 caregivers) or a usual care group (102 caregivers). As we have 6 trial centres, each centre will recruit 34 caregivers who will be randomly signed to either an iSupport group (17 caregivers), or a usual care group (17 caregivers).The interventions in the study are outlined in the following:
1. Self-learning of the online iSupport education program: The online program includes five learning modules and 23 units: (1) general information about dementia (1 unit); (2) information related to being a carer (4 units); (3) self-care (3 units); (4) providing care for the person with dementia (5 units); and (5) addressing symptoms of dementia (10 units). Each module presents a topic and provides interactive exercises with instant feedback for carers. When appropriate, the program introduces dementia care resources and services with weblinks for carers to access. Written short case scenarios are presented when appropriate to help carers understand the person-centred care approach for people with dementia and to develop problem-solving skills. It will take an average 2 hours for a carer to complete a unit. Carers will select at least 20 learning units that are relevant to them from the iSupport to learn over 6 months. The Online program will measure the completion of the program. Carers will receive an online certificate for each learning unit they have completed. They will also be able to print out their answers to questions in the exercises in each unit and review feedback on their answers. These records will also be used by the research team to assess the compliance with intervention and the outcomes of learning in carers.
2. Virtual caregiver support groups: A trained health professional (THP) will assign carers into support groups of 6 people. The THP will facilitate carers to share their learning and experiences through a monthly carer support group meeting (lasting 45 minutes) and chats via a social media platform of their choice over 6-months. The meetings will be recorded as qualitative data to analyze carers’ experience in the program. Caregivers will follow an agreed protocol to maintain confidentiality and privacy in group activities.
3. The trained program facilitators are health professionals with dementia care expertise and experience. They will complete 2x 2 hours online training modules specific to the intervention activities designed by the project team.
Intervention code [1] 319242 0
Treatment: Other
Comparator / control treatment
Caregivers in the usual care group will be supported by usual support provided by Alzheimer’s associations in their region including Dementia Australian, Alzheimer’s Disease China (ADC), Taiwan Alzheimer’s Disease Association (TADA), Hong Kong Alzheimer’s Disease Association (HKADA) and Macau Alzheimer’s Disease Association (MADA). The usual support entails readily available information sheets, carer group meetings etc. that are public available and freely accessible for carers.
Control group
Active

Outcomes
Primary outcome [1] 325927 0
Caregivers‘ quality of life will be assessed as our primary outcome. The 12-Item Short-Form Health Survey (SF-12) will be used to measure QoL in two domains: mental health-related Quality of Life (QoL) and physical health-related QoL.
Timepoint [1] 325927 0
The questionnaire will be completed at baseline, 6 months and 9 months post-initiation of the intervention.
Secondary outcome [1] 389556 0
The Revised Scale for Caregiving Self-Efficacy (RSCSE) will be used to determine caregivers' self-efficacy.
Timepoint [1] 389556 0
Baseline, 6 months and 9 months post-initiation of the intervention.
Secondary outcome [2] 389557 0
Quality of social support for dementia caregivers will be assessed with the Quality of Social Support subscale of the Carers of Older People in Europe Index.
Timepoint [2] 389557 0
Baseline, 6 months and 9 months post-initiation of the intervention .
Secondary outcome [3] 389558 0
Revised Memory and Behaviour Problem Checklist includes 24 items measuring the frequency of atypical behavior of people with dementia and carer reaction to those behaviors in three subscales: depression, disruption and memory-related problems.
Timepoint [3] 389558 0
Baseline, 6 months and 9 months post-initiation of the intervention .
Secondary outcome [4] 389559 0
The quality of life for people with dementia under the care of the study participants will be assessed with The Quality of Life in Alzheimer’s Disease (QOL-AD)-Proxy.
Timepoint [4] 389559 0
Baseline, 6 months and 9 months post-initiation of the intervention.
Secondary outcome [5] 389560 0
Unplanned hospital admissions for the care recipients will be measured using the Chinese version of "Resource Utilisation in Dementia (RUD) Lite Questionnaire" (Wimo A, Wetterholm, Mastey, & Winblad, 1998).
Timepoint [5] 389560 0
Baseline and then every month for 5 months during the 6 month trial.
Secondary outcome [6] 391169 0
Emergency department use for the care recipients will be measured using the Chinese version of "Resource Utilisation in Dementia (RUD) Lite Questionnaire" (Wimo A, Wetterholm, Mastey, & Winblad, 1998).
Timepoint [6] 391169 0
Baseline and then every month for 5 months during the 6 month trial.
Secondary outcome [7] 391170 0
Permanent admission to nursing homes for the care recipientswill be measured using the Chinese version of "Resource Utilisation in Dementia (RUD) Lite Questionnaire" (Wimo A, Wetterholm, Mastey, & Winblad, 1998).
Timepoint [7] 391170 0
Baseline and then every month for 5 months during the 6 month trial.
Secondary outcome [8] 391171 0
Cost-effectiveness will be calculated in the following methods: 1. Resource use for care recipients regarding hospital admission, the use of emergency department, nursing home care, carers' time spent on care activities and medication usage will be recorded using "Resource Utilisation in Dementia (RUD) Lite Questionnaire". The costs associated with development and administration of the programme will also be calculated using the project cost record. 2. SF-12 responses between baseline and 6 months will be converted into health state utilities for the calculation of QALYs for carers using the SF-6D preference based scoring algorithm developed by Brazier and colleagues; 3. QOL-AD-Proxy responses will be similarly converted using the preference based scoring algorithm developed by Comans and colleagues.
Timepoint [8] 391171 0
Baseline and then every month for 5 months during the 6 month trial.

Eligibility
Key inclusion criteria
Participants will be recruited from six sites as listed following: Adelaide, Beijing, Xi'an, Taipei, Hong Kong, and Macau.

Inclusion criteria for caregivers: (1) primary family carers aged 18 years or over who live in the same house with a person with dementia and provide care on a daily basis; (2) the person with dementia whom they care for has mild to moderate dementia consistent with a score between 10 and 23 using the Mini-Mental State Examination, and (3) the carers are internet users.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria: (1) carers have severe mental health conditions or terminal illness, (2) carers involved in other studies, and (3) carers who cannot read Chinese without assistance.

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 the research assistant into sequentially numbered, opaque, sealed envelopes.
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 iSupport or the usual care. 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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
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 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 RA, who will be blinded to group assignments, will undertake data analysis and will be supervised by AI Ullah, a biostatistician.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2021
Actual
1/11/2021
Date of last participant enrolment
Anticipated
30/12/2021
Actual
30/06/2022
Date of last data collection
Anticipated
30/03/2023
Actual
6/10/2023
Sample size
Target
204
Accrual to date
Final
204
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment outside Australia
Country [1] 23274 0
China
State/province [1] 23274 0
Beijing
Country [2] 23275 0
China
State/province [2] 23275 0
Shaanxi
Country [3] 23276 0
China
State/province [3] 23276 0
Taiwan
Country [4] 23277 0
China
State/province [4] 23277 0
Hong Kong
Country [5] 23278 0
China
State/province [5] 23278 0
Macau

Funding & Sponsors
Funding source category [1] 307370 0
Government body
Name [1] 307370 0
National Foundation for Australia-China Relations 2020-21 Competitive Grants Program
Country [1] 307370 0
Australia
Primary sponsor type
Government body
Name
National Foundation for Australia-China Relations
Address
Suite 4502, Australia Square
264 George Street, Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 308025 0
None
Name [1] 308025 0
None
Address [1] 308025 0
None
Country [1] 308025 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307458 0
Human Research Ethics Committee, Flinders University
Ethics committee address [1] 307458 0
Ethics committee country [1] 307458 0
Australia
Date submitted for ethics approval [1] 307458 0
12/10/2020
Approval date [1] 307458 0
27/11/2020
Ethics approval number [1] 307458 0
2782

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

Contacts
Principal investigator
Name 107302 0
Prof Lily Xiao
Address 107302 0
College of Nursing and Health Sciences
Flinders University
Sturt Road, Bedford Park
5042 GPO Box 2100
Adelaide SA
Country 107302 0
Australia
Phone 107302 0
+61 8 82013419
Fax 107302 0
+61 8 82761602
Email 107302 0
[email protected]
Contact person for public queries
Name 107303 0
Lily Xiao
Address 107303 0
College of Nursing and Health Sciences
Flinders University
Sturt Road, Bedford Park
5042 GPO Box 2100
Adelaide SA
Country 107303 0
Australia
Phone 107303 0
+61 8 82013419
Fax 107303 0
+61 8 82761602
Email 107303 0
[email protected]
Contact person for scientific queries
Name 107304 0
Lily Xiao
Address 107304 0
College of Nursing and Health Sciences
Flinders University
Sturt Road, Bedford Park
5042 GPO Box 2100
Adelaide SA
Country 107304 0
Australia
Phone 107304 0
+61 8 82013419
Fax 107304 0
+61 8 82761602
Email 107304 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?
Each participant in the study will be assigned a unique code to protect their identity. Individual, de-identified data underlying published results will be shared such as the scores of each time point of participants.
When will data be available (start and end dates)?
Immediately following findings from the study published in the review journals related to this topic, no end date.
Available to whom?
Available to researchers for academic use.
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Access to get the approvals by 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?

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.