Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001452886
Ethics application status
Approved
Date submitted
9/09/2021
Date registered
25/10/2021
Date last updated
27/10/2023
Date data sharing statement initially provided
25/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
e-DiVA (empowering Dementia Carers with an iSupport Virtual Assistant)
Scientific title
Feasibility and Acceptability of e-DiVA (empowering Dementia Carers with an iSupport Virtual Assistant)
Secondary ID [1] 303068 0
None
Universal Trial Number (UTN)
U1111-1263-0506
Trial acronym
e-DIVA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia
 320137 0
Condition category
Condition code
Mental Health 318079 318079 0 0
Depression
Public Health 318080 318080 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Six versions of the iSupport VA will be built from the content of the adapted iSupport. The VA will be designed to make the iSupport program easier and simpler to use on all device types including smart phones, tablets, laptop and desktop computers.

The VA will first ask individual carers in country appropriate language to undergo an assessment of their key education and support needs. Using the finding of this initial need assessment, the algorithm of the VA will provide tailored interventions (i.e. recommending specific lessons and videos in the iSupport program) to match each individual’s need profiles. The VA will provide text or voice command search options. The search outcomes will be in text, picture or video formats with detailed instructions. Users can choose specific lessons or any part of the program simply by selecting a specific topic.

Online links for existing health and well-being, aged and social care services for dementia and other important information (e.g. email, emergency contact numbers etc.) in each country will be incorporated in VA versions. With carers’ consent, the VA will support online peer support groups. These online support groups will enable sharing of experiences, practical tips and peer support, in either real time video or text chat among logged in members, or by an asynchronous messaging system. The app will have capability for a "Personal Diary" for users to write their action plans or scheduled medical appointments and will remind users to follow the scheduled plans and appointments.

Participants will be asked to use the iSupport VA at least 1 hour each week for 6 months.

Monthly phone contact with carers will be also conducted to assess their use of the intervention. Notes from these contacts will be recorded. A local research team member fluent in country appropriate language will be available and contactable by telephone and/or email if carers need technical assistance.
Intervention code [1] 319354 0
Treatment: Devices
Intervention code [2] 319355 0
Lifestyle
Intervention code [3] 319356 0
Behaviour
Comparator / control treatment
Those in the waiting list control group will also receive the iSupport VA. However, they will be informed that they will receive login details for iSupport VA after completing the 3-month assessment. Following their 3-month assessment completion, all waiting list control carers will have full access to iSupport VA for three months, which will enlarge the number of dementia carers to access the iSupport VA in this pilot RCT.
Control group
Active

Outcomes
Primary outcome [1] 326108 0
The intervention feasibility will be evaluated regarding recruitment, randomisation, retention, treatment adherence, and assessment processes. The feasibility will be assessed by the user log history in the iSupport VA platform.
Recruitment feasibility: the number of carers screened to identify carers who meet eligibility criteria.
Randomisation feasibility: the percent of eligible carers who agree to randomisation.
Timepoint [1] 326108 0
3 months after baseline (t1)
6 months after baseline (t2)
Primary outcome [2] 326109 0
At the end of the RCT, carers in the intervention group (10 per iSupport VA version) will undergo a 30-60-minute semi-structured exit interview to assess iSupport VA acceptability, including most and least relevant and helpful aspects, the main barriers and facilitators of using the VA, and recommended improvements.
Timepoint [2] 326109 0
6 months after baseline (t2)
Primary outcome [3] 329316 0
At the end of the RCT, all 140 carers will be asked to complete a questionnaire to assess their intention to use the iSupport VA. The questionnaire will include one question: “How will you (dementia carer) use the iSupport VA in the coming six months?”
Timepoint [3] 329316 0
6 months after baseline (t2)
Secondary outcome [1] 390142 0
The secondary outcomes will include change in perceived stress assessed by Perceived Stress Scale (PSS) at t1, t2.
Timepoint [1] 390142 0
Baseline (t0)
3 months after baseline (t1)
6 months after baseline (t2)
Secondary outcome [2] 402113 0
The secondary outcomes will include change in psychological distress (PHQ-9) at t1, t2.
Timepoint [2] 402113 0
Baseline (t0)
3 months after baseline (t1)
6 months after baseline (t2)
Secondary outcome [3] 402285 0
The secondary outcomes will include change in health-related quality of life (global Visual Analogue Scale) and carer burden (Zarit Burden Interview (ZBI-4)) at t1, t2
Timepoint [3] 402285 0
Baseline (t0)
3 months after baseline (t1)
6 months after baseline (t2)

Eligibility
Key inclusion criteria
Participants eligible for the pilot RCT study will:
(1) be adults (greater than or equal to 18 years) residing in one of the four countries;
(2) be a primary unpaid carer of a community-dwelling person with dementia (having a formal diagnosis of dementia as reported by the carer or an Ascertain Dementia 8-item Informant Questionnaires (AD-8) score greater than or equal to 2; or Rowland Universal Dementia Assessment Scale (RUDAS score =22));
(3) have been providing care for greater than or equal to 6 months;
and (4) experience stress (a Perceived Stress Scale (PSS) score greater than 13)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria are
(1) inability to comprehend any of the designated languages;
(2) having cognitive impairment (Mini-Cog™ score smaller than 4);
(3) having significant vision impairment (cannot read what is on the screen to respond appropriately);
(4) having hearing impairment (cannot hear the question what is your name on the telephone to respond appropriately);
(5) participation in the adaptation and development process of iSupport VA;
(6) no experience in using internet or apps on devices;
and (7) no access to a device with an internet connection.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After enrolment, carers will be randomised separately for each iSupport VA version to either intervention or waiting list control groups (1:1 ratio). A permuted block randomisation of size four will be used to ensure an even balance of carers in each group throughout the study period. A central clinical trials service in Australia will undertake randomisation for each iSupport version in four countries.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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
Recruitment feasibility will be assessed by the number of carers screened to identify carers who meet eligibility criteria. Randomisation feasibility will be assessed based on the percent of eligible carers who agree to randomisation. Subject retention in both arms of the study will be evaluated. We will also track intervention adherence (e.g. % completing lessons, watching videos). We will assess the feasibility of assessing study outcomes in terms of percent of baseline, 3- and 6-month assessments completed, and completeness of collected data.

The criteria for determining feasibility success will be: (1) average of three carers per iSupport version per month (about 140 carers for six iSupport VA versions in four countries over 7 months) can be recruited; (2) at least 70% of all eligible carers can be recruited; (3) complete baseline and follow-up assessments by at least 70% of all recruited carers. iSupport VA acceptability will be analysed thematically. Association between the UTAUT construct and the intention to use iSupport VA will be assessed using logistic regressions. For preliminary impact assessment, linear mixed-effects modelling will be used to analyse changes in primary and secondary outcomes from baseline to three and six months. For dichotomous or non-continuous outcome measures, appropriate generalized linear mixed-effects models will be applied. All analyses will be adjusted for language version. One chief investigator of the project is a biostatistician, who will support the research and RCT from designing, collecting, analysing and presenting the data. A detailed statistical analysis plan will be developed before unbinding the data and any analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2023
Actual
Date of last participant enrolment
Anticipated
31/03/2024
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment outside Australia
Country [1] 23352 0
New Zealand
State/province [1] 23352 0
Auckland
Country [2] 23353 0
Indonesia
State/province [2] 23353 0
Jakarta
Country [3] 23354 0
Viet Nam
State/province [3] 23354 0
Hanoi

Funding & Sponsors
Funding source category [1] 307475 0
Government body
Name [1] 307475 0
NHMRC
Country [1] 307475 0
Viet Nam
Funding source category [2] 307496 0
Government body
Name [2] 307496 0
Ministry of Sciences and Technology
Country [2] 307496 0
Indonesia
Funding source category [3] 307497 0
Government body
Name [3] 307497 0
Ministry of Research and Technology, Indonesia
Country [3] 307497 0
Indonesia
Funding source category [4] 307498 0
Government body
Name [4] 307498 0
Health Research Council
Country [4] 307498 0
New Zealand
Primary sponsor type
Other
Name
National Ageing Research Institute
Address
34-54 Poplar Road, Gate 4, Building 8 (PO Box 2127)
Royal Melbourne Hospital Victoria 3050 Australia
Country
Australia
Secondary sponsor category [1] 308146 0
University
Name [1] 308146 0
The University of Aukland
Address [1] 308146 0
24 Symonds St City Campus, Auckland 1010
Country [1] 308146 0
New Zealand
Secondary sponsor category [2] 308176 0
University
Name [2] 308176 0
Atma Jaya Catholic University of Indonesia
Address [2] 308176 0
BPP Teknologi II Building 5th - 8th and 24th Floor Central Jakarta, Jakarta 10340
Country [2] 308176 0
Indonesia
Secondary sponsor category [3] 308177 0
University
Name [3] 308177 0
Vietnam National Geriatric Hospital
Address [3] 308177 0
114 Phuong Mai Street, Dong Da District, Hanoi, 10000
Country [3] 308177 0
Viet Nam
Other collaborator category [1] 281577 0
Other
Name [1] 281577 0
World Health Organisation
Address [1] 281577 0
885 2nd Ave, New York NY 10017
Country [1] 281577 0
United States of America
Other collaborator category [2] 281578 0
Other
Name [2] 281578 0
Alzheimer's Disease Internationals
Address [2] 281578 0
57a Great Suffolk St, London SE1 0BB, United Kingdom
Country [2] 281578 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307551 0
University of South Australia
Ethics committee address [1] 307551 0
Ethics committee country [1] 307551 0
Australia
Date submitted for ethics approval [1] 307551 0
01/03/2021
Approval date [1] 307551 0
23/04/2021
Ethics approval number [1] 307551 0
203455

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

Contacts
Principal investigator
Name 107642 0
A/Prof Tuan Anh Nguyen
Address 107642 0
Senior Research Fellow,
National Ageing Research Institute, Royal Melbourne Hospital, Royal Park Campus, Gate 4, Building 8, 34-54 Poplar Rd, Parkville VIC 3052
Country 107642 0
Australia
Phone 107642 0
+61 3 8387 2305
Fax 107642 0
Email 107642 0
t.nguyen@nari.edu.au
Contact person for public queries
Name 107643 0
Kham Van Tran
Address 107643 0
National Ageing Research Institute, Royal Melbourne Hospital, Royal Park Campus, Gate 4, Building 8, 34-54 Poplar Rd, Parkville VIC 3052
Country 107643 0
Australia
Phone 107643 0
+61 4 04334 762
Fax 107643 0
Email 107643 0
kham.tran@unisa.edu.au
Contact person for scientific queries
Name 107644 0
Tuan Anh Nguyen
Address 107644 0
Senior Research Fellow,
National Ageing Research Institute, Royal Melbourne Hospital, Royal Park Campus, Gate 4, Building 8, 34-54 Poplar Rd, Parkville VIC 3052
Country 107644 0
Australia
Phone 107644 0
+61 3 8387 2305
Fax 107644 0
Email 107644 0
t.nguyen@nari.edu.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10148Study protocol  kham.tran@unisa.edu.au
10150Ethical approval  kham.tran@unisa.edu.au 381146-(Uploaded-29-09-2021-09-40-47)-Study-related document.pdf
13396Informed consent form  k.tran@nari.edu.au 381146-(Uploaded-29-09-2021-09-49-58)-Study-related document.docx



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.