Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000199718
Ethics application status
Approved
Date submitted
18/01/2022
Date registered
4/02/2022
Date last updated
13/10/2024
Date data sharing statement initially provided
4/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Creating ‘Partnership in iSupport program’ to optimise carers’ impact on dementia care
Scientific title
‘Partnerships in iSupport program’ to optimise carers’ impact on dementia care: A randomised controlled trial
Secondary ID [1] 302950 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 319866 0
Condition category
Condition code
Neurological 317803 317803 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The planned interventions are described in the following.
(1) Managing transitions: In each study site, carers will be assigned to an iSupport program facilitator and encouraged to request individualised support from the facilitator during transition between care settings (i.e. from hospital to home transitional care) and types (i.e. receiving ambulatory geriatric services, or rehabilitation or palliative care at home in addition to usual home care package) of the persons living with dementia (PLWD). Carers will make the request by phone or email. The individualised support for carers will be administered using phone or Zoom (an online meeting platform), which will be organised by the facilitator. The anticipated time spend on this type of support will be 1-2 hours per week per carer or based on the carer’ needs and discretion. The time the facilitator spends on supporting each individual carer will be record as part of data for analysis.
(2) Managing dementia progression: Carers are also encouraged to contact the facilitator to discuss changes in PLWD (i.e., signs of deterioration, changed behaviours and complications) and gain advice to access relevant multidisciplinary care services for timely treatment and care. The facilitator will follow the carers until their needs for support have been met. The individualised support for carers will be administered using phone or Zoom. The anticipated time spend on this type of support will be 1-2 hours per week per carer or based on the carer’ needs and discretion. The time the facilitator spends on supporting each individual carer will be record as part of data for analysis.
(3) Psychoeducation: Carers will select at least 20 out of 30 learning units that are relevant to them from the online iSupport program or a hardcopy iSupport manual to learn over the first 6 months of the trial and revisit or learn new units when they feel it is needed in the second 6 months. The learning unites include short readings, case studies and interactive activities using multiple choice questions and answers. The expected time spent on learning the online iSupport learning modules is no more than 12 hours in total. The completion of each unit will be measured through the program design and will be recorded as data for compliance with the intervention. Carers will receive a certificate for each unit they complete, a strategy to motivate them in the program.
(4) Carer support group: In each study site, the facilitator will assign the 23 carers into one of two support groups. The facilitator will conduct a monthly online carer support group meeting using the Zoom meeting platform and lasting no more than 30 minutes. Managing transitions between care settings and types and managing disease progression will be standard meeting agenda so that carers can share their experiences and support each other in these dementia caregiving areas. The meetings will be recorded for carers in the same group to access. The facilitator will also create carer support groups in in WhatsApp to encourage carers to talk or send text messages to their peers in the same group to strengthen social support. Facilitator will communicate with participants via phone calls if they have no access to zoom or WhatsApp. The facilitator will analyse group interactions, investigate carers’ needs for support and provide feedback to them. Attendance at monthly group meetings via Zoom, the messages shared by carers in chat groups and the amount of time each carer spends in a chat group via WhatsApp will be recorded as part of data for analysis.
(5) Feedback on services: The facilitators will collect carers’ feedback via regular carer support meetings and discuss the feedback in their organisation’s quality improvement meetings.
Intervention code [1] 319158 0
Treatment: Other
Comparator / control treatment
Carers will receive the usual carer support provided by Dementia Australia or other publicly funded carer support. They will receive a monthly reminder email that directs them to the Dementia Australia website where they can seek support if they wish.
Control group
Active

Outcomes
Primary outcome [1] 325829 0
Carers' quality of life using 12-Item Short-Form Health Survey (SF-12).
Timepoint [1] 325829 0
At baseline, 6 months (primary timepoint) and 12 months post-initiation of the intervention.
Primary outcome [2] 325835 0
Care recipients’ Quality of Life in Alzheimer’s Disease (QOL-AD)-Proxy
Timepoint [2] 325835 0
At baseline, 6 months (primary timepoint) and 12 months post-initiation of the intervention.
Secondary outcome [1] 389251 0
Caregiving Self-Efficacy Scale
Timepoint [1] 389251 0
At baseline, 6 months and 12 months post-initiation of the intervention.
Secondary outcome [2] 389267 0
The Carers of Older People in Europe Index-Quality of Social Support (The COPE Index-QS)
Timepoint [2] 389267 0
At baseline, 6 months and 12 months post-initiation of the intervention.
Secondary outcome [3] 389268 0
The Revised Memory and Behaviour Problem Checklist
Timepoint [3] 389268 0
At baseline, 6 months and 12 months post-initiation of the intervention.
Secondary outcome [4] 389269 0
The incremental gains in quality adjusted life years (QALYs) for carers.
Timepoint [4] 389269 0
Between baseline and 12 months post-initiation of the intervention.
Secondary outcome [5] 404862 0
The incremental gains in quality adjusted life years (QALYs) for people with dementia.
Timepoint [5] 404862 0
Between baseline and 12 months post-initiation of the intervention.
Secondary outcome [6] 404996 0
Health service use for carers and people with dementia using linked administrative health data from Data Linkage Services, including Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule (MBS) utilisation, and hospital and emergency department uses
Timepoint [6] 404996 0
12 months prior and 12 months post-initiation of the intervention.
Secondary outcome [7] 404997 0
Health and social care visits of carer and people with dementia outside those provided by MBS using the resource utilisation in dementia (RUD) questionnaire
Timepoint [7] 404997 0
At baseline and then every month for 12 months during the 12 month trial.

Eligibility
Key inclusion criteria
The carer need to meet these conditions: (1) The carer is aged 18 years or over; (2) The carer provides care support for a person living with dementia at least twice a week; (3) if a care recipient has no formal dementia diagnosis but meets the following three criteria: a) cognitive impairment using MMSE to measure or other validated tools (GDS or RUDAS) to measure; b) self-care decline and c) changed behaviours using the valid ‘Blessed Dementia Dependence Score’ .
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Carers will be excluded if they (1) have health conditions that may significantly impact their ability to participate in the study; (2) involve in other studies, and (3) cannot read English without additional 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 as allocation will be undertaken in an independent clinical trial management centre,
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To ensure the two groups are of equivalent size and conditions, a block randomisation will be used to allocate carers to one of the two treatment groups for each recruitment site. Stratification will also be used in the block randomisation to ensure equivalent distribution of spouse carers versus non-spouse carers and care recipients with mild versus moderate dementia in each treatment group. Site-specific researchers who enrol carers in the study provide these information categories to a senior statistician to provided randomisation. The statistician is blinded to participants and is not involved in data analysis.
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
Intervention effectiveness: Data will be analysed on an intention-to-treat basis based on group assignments. Descriptive statistics will be applied to summarise data. Binary correlation analysis will be performed to compare group using baseline data. 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.

Cost-effectiveness: 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. DEMQOL-Proxy responses will be similarly converted into health state utilities for the calculation of QALYs for people with dementia using the preference-based scoring algorithm. Data on health and social care service use for carers and care recipients will be collected via interview from the carers using the RUD monthly. Pre-baseline resource use data will provide additional baseline variables to control for potential confounding. The difference between pre- and post-baseline use of health services will be used to measure changes in carers’ and care recipients’ levels of utilisation and cost of health services for participants in both study arms. Unit costs will be derived from following guidelines for conducting economic evaluations in Australia from published sources provided by Medicare, hospital finance departments and Australian Refined Diagnosis Related Groups cost weights. Cost of nursing home care will be calculated using basic daily and accommodation fees apportioned according to length of stay. An assessment of the sensitivity of the results obtained to variation in measured resources, effectiveness and/or unit costs will be undertaken using appropriate one-way and multi-way sensitivity analysis.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
1/07/2022
Date of last participant enrolment
Anticipated
31/12/2023
Actual
31/12/2023
Date of last data collection
Anticipated
20/01/2025
Actual
Sample size
Target
130
Accrual to date
Final
149
Recruitment in Australia
Recruitment state(s)
ACT,SA,VIC

Funding & Sponsors
Funding source category [1] 307287 0
Government body
Name [1] 307287 0
National Health and Medical Research Council (Medical Research Future Fund [MRFF] 2020 Dementia Ageing and Aged Care grant
Country [1] 307287 0
Australia
Funding source category [2] 310291 0
Other Collaborative groups
Name [2] 310291 0
Dementia Collaborative Research Centre (2020 DCRC World Class Research Project Grants)
Country [2] 310291 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders University
Sturt Road
Bedford Park
South Australia 5042
Country
Australia
Secondary sponsor category [1] 311744 0
Commercial sector/Industry
Name [1] 311744 0
Resthaven Inc. SA,
Address [1] 311744 0
6 Bartley Cres, Wayville SA 5034, Australia
Country [1] 311744 0
Australia
Secondary sponsor category [2] 311887 0
Commercial sector/Industry
Name [2] 311887 0
Bolton Clarke Victoria
Address [2] 311887 0
Level 1, 347 Burwood Highway Forest Hill, VIC 3131
Country [2] 311887 0
Australia
Secondary sponsor category [3] 311888 0
Hospital
Name [3] 311888 0
Southern Adelaide Local Health Network (SALHN)
Address [3] 311888 0
Flinders Medical Centre, Bedford Park SA 5042
Country [3] 311888 0
Australia
Secondary sponsor category [4] 311889 0
Hospital
Name [4] 311889 0
Canberra Health Services
Address [4] 311889 0
Canberra Hospital, Yamba Drive, Garran ACT 2605
Country [4] 311889 0
Australia
Secondary sponsor category [5] 311891 0
University
Name [5] 311891 0
University of South Australia
Address [5] 311891 0
101 Currie St, Adelaide SA 5001
Country [5] 311891 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307385 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 307385 0
Ethics committee country [1] 307385 0
Australia
Date submitted for ethics approval [1] 307385 0
22/12/2021
Approval date [1] 307385 0
02/05/2022
Ethics approval number [1] 307385 0
2021/HRE00288

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

Contacts
Principal investigator
Name 107046 0
Prof Lily Xiao
Address 107046 0
College of Nursing and Health Sciences
Flinders University
Sturt Road, Bedford Park
5042 GPO Box 2100
Adelaide SA
Country 107046 0
Australia
Phone 107046 0
+61 8 82013419
Fax 107046 0
+61 8 82761602
Email 107046 0
lily.xiao@flinders.edu.au
Contact person for public queries
Name 107047 0
Lily Xiao
Address 107047 0
College of Nursing and Health Sciences
Flinders University
Sturt Road, Bedford Park
5042 GPO Box 2100
Adelaide SA
Country 107047 0
Australia
Phone 107047 0
+61 8 82013419
Fax 107047 0
+61 8 82761602
Email 107047 0
lily.xiao@flinders.edu.au
Contact person for scientific queries
Name 107048 0
Lily Xiao
Address 107048 0
College of Nursing and Health Sciences
Flinders University
Sturt Road, Bedford Park
5042 GPO Box 2100
Adelaide SA
Country 107048 0
Australia
Phone 107048 0
+61 8 82013419
Fax 107048 0
+61 8 82761602
Email 107048 0
lily.xiao@flinders.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?
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: lily.xiao@flinders.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14885Ethical approval    380997-(Uploaded-22-11-2022-11-40-57)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCreating 'Partnership in iSupport program' to optimise family carers' impact on dementia care: a randomised controlled trial protocol.2022https://dx.doi.org/10.1186/s12913-022-08148-2
N.B. These documents automatically identified may not have been verified by the study sponsor.