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Trial registered on ANZCTR


Registration number
ACTRN12622000598785p
Ethics application status
Submitted, not yet approved
Date submitted
26/03/2022
Date registered
21/04/2022
Date last updated
21/04/2022
Date data sharing statement initially provided
21/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A tailored iSupport virtual group intervention for Chinese dementia carers living in New Zealand
Scientific title
A tailored iSupport virtual group intervention for Chinese dementia carers living in New Zealand: a pilot randomised controlled trial
Secondary ID [1] 306602 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementias 325512 0
Carer stress 325965 0
Condition category
Condition code
Neurological 322888 322888 0 0
Dementias
Other 323282 323282 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Chinese version of the iSupport manual has been culturally adapted for Chinese dementia carers living in New Zealand, and it will be used in this study. This manual contains five themes spread across 23 sessions: (1) what is dementia? (one sesson), (2) being a carer (four sessons), (3) caring for me (three sessons), (4) providing everyday care (five sessons), and (5) dealing with challenging behaviours (10 sessons). For the iSupport virtual group intervention, only 11 sessions will be used.

The development of the iSupport virtual group intervention was informed by the findings of a qualitative study interviewing Chinese dementia carers about their meaningful activities, digital ability, unmet needs, and usability of the Chinese version of the iSupport manual. These findings were used to tailor the iSupport virtual group intervention and to design the format of intervention delivery. The 11 lessons chosen by all the participants will be combined and prioritised by the research team. The 12 lessons of the iSupport virtual group intervention will be finalized from the findings of the interviews and 11 chosen lessons.

This iSupport virtual group intervention will consist of a 1.5-hour session per week for 12 weeks. The intervention group will be divided into two groups with 5-7 people in each group. Two trained facilitators (an Age Concern Auckland staff and a volunteer) will be assigned to each group. Each session follows a similar format, consisting of a presentation about the main topic of the session, small exercises (e.g., mindful breathing), questions & answers, a summary of the lesson plus homework (e.g., preparing questions for the upcoming session), and evaluation. In addition, each session will involve a peer who was an experienced dementia carer or a health professional (such as a nursing practitioner or old age psychiatrist).

After baseline assessment and randomisation, the participants in the intervention group will receive 12 sessions of the iSupport virtual group intervention. In addition, participants will receive all materials (The Chinese version of the iSupport manual and the iSupport virtual group intervention participant guide) for self-learning two weeks before starting the intervention. Zoom will be used to deliver the iSupport virtual group intervention. One day before the intervention, participants will receive a text reminder of the Zoom link and ID. Adherence to the intervention will be monitored using a spreadsheet before the start of each session.
Intervention code [1] 323054 0
Treatment: Other
Comparator / control treatment
Dementia carers in the control group will receive a minimal active intervention. The intervention consists of self-learning the iSupport manual with practical information about caring for PLwD. A hard copy and the PDF version of the iSupport manual will be sent to the carers two weeks before starting the baseline intervention. Carers will have unlimited access to the iSupport manual.
Control group
Active

Outcomes
Primary outcome [1] 330679 0
Caregivers‘ stress will be assessed as our primary outcome. Stress (measured by Perceived Stress Scale)
Timepoint [1] 330679 0
Baseline and 12 weeks post-intervention
Primary outcome [2] 330972 0
Feasibility data will be assessed as a composite primary outcome. As this is a pilot study, the feasibility data will explore the feasibility issues of the new intervention. It will be collected in four metrics, including resources, process, management, and scientific feasibility.
(1) The resources data will be collected from the appropriateness of eligibility criteria (details of reasons individuals are excluded from participation as documented in the study enrolment logs), time (time to complete the assessments and consent and the time to enrol participants as documented in the study-specific database), session attendance logs (review of session attendance logs), and retention (percentage of participants enrolled in the study who completed the intervention determined by an audit of study enrolment logs).
(2) The process feasibility data will be collected from recruitment (the feasibility of recruiting approaches as documented in the study enrolment logs) and determine the ease of randomisation (the willingness of participants to be randomised to the intervention group as documented in the study randomisation logs).
(3) Management feasibility data will be collected from facilitator training (evaluation and feedback on the training workshop will be provided by Age Concern staff and volunteers); Intervention delivery (active feedback from the participants will be collected at the end of each session); Supervision of group facilitators (the frequency, duration and acceptability of online supervision will be assessed through active feedback from the group facilitators).
(4) Scientific feasibility data (Safetywill be assessed through the review of any adverse events, including distress, that occur during the intervention. These events will be self-reported by participants).
Timepoint [2] 330972 0
Participant recuitment, baseline assessment, weekly during the 12 weeks intervention period, and one week post-intervention completion.
Secondary outcome [1] 407192 0
Burden (measured by Zarit Burden Scale)
Timepoint [1] 407192 0
Baseline and one week post-intervention completion
Secondary outcome [2] 407193 0
Social support (measured by Social Support Rating Scale)
Timepoint [2] 407193 0
Baseline and one week post-intervention completion
Secondary outcome [3] 407194 0
Quality of life (measured by the 12-Item Short-Form Health Survey (SF-12))
Timepoint [3] 407194 0
Baseline and one week post-intervention completion
Secondary outcome [4] 407195 0
Cultural (measured by Cultural Justification for Caregiving Scale)
Timepoint [4] 407195 0
Baseline and one week post-intervention completion
Secondary outcome [5] 407196 0
Resilience (measured by Resilience Scale for Adults)
Timepoint [5] 407196 0
Baseline and one week post-intervention completion
Secondary outcome [6] 408321 0
A semi-structured interview about the participants’ experiences of the iSupport virtual group intervention will be conducted on individuals from the intervention group. The themes will likely be structured around the topics in the interview guide (general opinions about the intervention; motivation of intervention involvement; positive aspects of the intervention; challenges or opportunities for intervention improvement; likelihood to utilise a similar programme in the future).
Timepoint [6] 408321 0
One week post-intervention completion

Eligibility
Key inclusion criteria
Inclusion criteria:
• aged 18 years (self-identified) or older AND
• members of Dementia Auckland, Age Concern Auckland, Dementia Canterbury, or Dementia Wellington AND
• provide practical support with domestic and/or personal activities to the person with dementia for a minimum of 4 hours per week AND
• be able to converse in Mandarin or Cantonese AND
• 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:
• carers with visual communication disorders or hearing disorders that may interfere with their ability to participate in the study AND/OR
• unable to provide informed consent.

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)
The allocation sequence will be concealed from the researcher enrolling participants by each allocation being contained in an opaque, sealed, sequentially numbered envelope. Each new participant will be given their allocation after consent to take part has been given and baseline assessments have been made.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following the baseline assessment, the participants will be randomly assigned into one of two groups (experimental group or control group) by using a computer-generated list. Random allocation will incorporate randomised blocks of 4 participants to ensure a balanced design at any time during the trial. Block randomisation will be performed centrally by an independent researcher who is not involved in the day to day running of the trial.


Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Qualitative analysis
A semi-structured interview about the participants’ experiences of the iSupport virtual group intervention will be conducted on individuals from the intervention group. The semi-structured interviews will be audio-recorded and transcribed. A researcher will analyse the data within NVivo-12 by using thematic analysis.

Quantitative analysis
The main analysis will be the person-centred outcome measures. Descriptive statistics will be calculated for demographics, questionnaires, and feasibility data. The baseline characteristics will be presented descriptively for dementia carers. Descriptive statistics of the mean /median, standard deviation /interquartile ranges will be used to analyse continuous variables, while categorical data will be calculated in numbers and percentages. To estimate data variability, between-group differences for all primary and secondary outcomes will be adjusted for baseline values, age, gender, and education.

A secondary aim is to estimate the effect of the iSupport virtual group intervention on every person-centred outcome. Based on the intent-to-treat principle, all analyses will be performed using IBM SPSS (Statistical Package for the Social Sciences) software, version 27.0, The level of statistical significance will be set at P<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
Date of last participant enrolment
Anticipated
30/07/2022
Actual
Date of last data collection
Anticipated
30/04/2023
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 24647 0
New Zealand
State/province [1] 24647 0

Funding & Sponsors
Funding source category [1] 310940 0
University
Name [1] 310940 0
University of Auckland
Country [1] 310940 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
School of Nursing, Faculty of Medicine and Health Sciences, Park Rd, Grafton, Auckland, 1010
Country
New Zealand
Secondary sponsor category [1] 312232 0
None
Name [1] 312232 0
Address [1] 312232 0
Country [1] 312232 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310493 0
Central Health and Disability Ethics Committee New Zealand
Ethics committee address [1] 310493 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 310493 0
New Zealand
Date submitted for ethics approval [1] 310493 0
08/04/2022
Approval date [1] 310493 0
Ethics approval number [1] 310493 0

Summary
Brief summary
Dementia carers may face more stressful events than general people during the COVID-19 pandemic. To maintain mental wellbeing, online delivery interventions hold the advantages of flexibility, cost-efficiency, and increased abilities. However, current iSupport online programmes trials reported a low adherence rate, and their efficacy is uncertain. To address these research gaps, we developed an iSupport virtual group intervention to improve or maintain the mental wellbeing of dementia carers based on a participant-centred approach.

This pilot study will explore the feasibility of an iSupport virtual group intervention to improve or maintain the mental wellbeing of Chinese dementia carers. The findings from this intervention study will provide evidence for intervention refinements and will inform the development of a full-powered RCT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117866 0
A/Prof John Parsons
Address 117866 0
School of Nursing, Faculty of Medical and Health Sciences, University of Auckland, 85 Park Road, Grafton, Auckland 1142,
Country 117866 0
New Zealand
Phone 117866 0
+64211267665
Fax 117866 0
Email 117866 0
j.parsons@auckland.ac.nz
Contact person for public queries
Name 117867 0
Ms Fei Li
Address 117867 0
School of Nursing, Faculty of Medical and Health Sciences, University of Auckland, 85 Park Road, Grafton, Auckland 1142,
Country 117867 0
New Zealand
Phone 117867 0
+64 2108828526
Fax 117867 0
Email 117867 0
fli745@aucklanduni.ac.nz
Contact person for scientific queries
Name 117868 0
Dr Gary Cheung
Address 117868 0
Department of Psychological Medicine, School of Medicine,
Faculty of Medical and Health Sciences,
University of Auckland, Auckland, 22-30 Park Avenue, Grafton, Auckland 1023
Country 117868 0
New Zealand
Phone 117868 0
+64 21332823
Fax 117868 0
Email 117868 0
g.cheung@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We are not seeking consent to allow this as it could compromise participant anonymity or privacy.


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15336Study protocol  fli745@aucklanduni.ac.nz 383702-(Uploaded-15-04-2022-18-17-23)-Study-related document.docx


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15336Study protocol  fli745@aucklanduni.ac.nz 383702-(Uploaded-19-06-2022-08-09-38)-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
No additional documents have been identified.