Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000813684p
Ethics application status
Submitted, not yet approved
Date submitted
13/07/2023
Date registered
28/07/2023
Date last updated
28/07/2023
Date data sharing statement initially provided
28/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
MinDArT and a Memory Cafe: A crossover trial testing the effect of mindful drawing and social interventions on stress in people living with dementia and their supporters
Scientific title
MinDArT and a Memory Cafe: A crossover trial testing the effect of mindful drawing and social interventions on stress in people living with dementia and their supporters
Secondary ID [1] 309995 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 330685 0
Condition category
Condition code
Neurological 327505 327505 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MinDArT is an eight-week dual-care programme for people with dementia and their supporters. Each 90 minute weekly session involves groups of 9 people with dementia undertaking custom-designed material and digital drawing exercises, while their supporters in an adjacent room undertake the same drawing programme. The drawing programme is inspired by nature, engaging as many senses as possible and applying repetitive drawing movements. Each session utilises natural resources, traditional drawing materials and a specially designed digital drawing application. The MinDArT digital applications are unique to the programme.
Additionally, each participant is given a digital tablet for the duration of the programme so that they can repeat the sessions at home. This allows them to access the benefits of the digital drawing programme at their own leisure until they are presented with the next instalment the following week.
MinDArT combines the principles of mindfulness with the meditative qualities of drawing, and incorporates physical creative activities with specially designed digital art activities on tablets.
The sessions will be run by the principal researcher (art lecturer) and Dementia Wellington Advisor. Session attendance will be recorded on a checklist.
There will be a 10 week washout period between each stage.

Intervention code [1] 326519 0
Treatment: Other
Comparator / control treatment
The participants will take part in eight 90 minute weekly Memory Cafe sessions. The involves a group of 9 people living with dementia and their care-partners meeting informally in a community location such as a neighbourhood cafe. The primary activity is informed discussion. A key aim of Memory Cafés is to increase the opportunity for connections with and social support for people with dementia and carers in a shared community setting.The format of the Memory Café used in this study is based on dementia Australia’s recommendation laid out in the manual ““Community Café Toolkit: Your manual and tools for establishing a café for people living with dementia” (Watson, Abbato, Westley, O’Louglin, and Costelloe, 2016). This will be facilitated by the principal researcher and past facilitators of MinDArT.
Control group
Active

Outcomes
Primary outcome [1] 335366 0
Outcome: Stress
Measure: Perceived Stress Scale (Cohen, 1994)
Timepoint [1] 335366 0
Pre-evaluation (baseline) versus post-evaluation (8 weeks post-baseline).
Secondary outcome [1] 424119 0
Outcome: Well-being
Measure: The World Health Organisation- Five Well-Being Index (WHO-5; World Health Organization, Regional office for Europe, 1998; Beech, 2004)
Timepoint [1] 424119 0
Pre-evaluation (baseline) versus post-evaluation (8 weeks post-baseline).
Secondary outcome [2] 424120 0
Outcome: Positive feelings about the support role for carers
Measure: Subscales from Caregiver Reaction Scale (CRS; Qualls & Kenny, 2008)
Timepoint [2] 424120 0
Pre-evaluation (baseline) versus post-evaluation (8 weeks post-baseline).
Secondary outcome [3] 424121 0
Outcome: Negative feelings about the support role for carers
Measure: Zarit 4-item Burden Scale (ZBI-4) (Bedard et al., 2001)
Timepoint [3] 424121 0
Pre-evaluation (baseline) versus post-evaluation (8 weeks post-baseline).
Secondary outcome [4] 424122 0
Outcome: Quality of life for people living with dementia
Measure: Dementia Quality of Life Instrument (DQOL) (Brod et al. in 1999)
Timepoint [4] 424122 0
Pre-evaluation (baseline) versus post-evaluation (8 weeks post-baseline).
Secondary outcome [5] 424123 0
Outcome: Manual dexterity
Participants: People living with dementia
Measure: The 9 hole peg test (Kellor et al. (1971; Mathiowetz et al, 1985)
Timepoint [5] 424123 0
Pre-evaluation (baseline) versus post-evaluation (8 weeks post-baseline).
Secondary outcome [6] 424124 0
Outcome: Cognition
Participants: People living with dementia
Measure: RUDAS (Rowland Universal Dementia Assessment Scale, Story et al, 2004)
Timepoint [6] 424124 0
Pre-evaluation (baseline) versus post-evaluation (8 weeks post-baseline).

Eligibility
Key inclusion criteria
The research is designed to be inclusive and will not exclude participants on the basis of their sexual orientation, gender, place of residence, ethnicity, nationality, religion, education or socioeconomic status.
The inclusion criteria are:
• Capacity to give informed consent to participate in this research.
• Able to converse in English without an interpreter
• The other half of dyad is available to participate (ie; carer)
• Service agency staff’s judgement that the person living with dementia will be able to comfortably meet the cognitive and communication demands of participating in this type of group session
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria are:
• Significant visual or hearing impairment to an extent that would make engagement in a group environment difficult.
• An activated enduring power of attorney for personal welfare and care (or clinician advice that they are cognitively unable to give informed consent).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
ANCOVA mixed model and standardised mean change
Sample size of 36 for crossover trial : 36 people living with dementia and 36 carers. This is adequate for medium effect size, alpha=.05, beta=.20

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/08/2023
Actual
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment outside Australia
Country [1] 25643 0
New Zealand
State/province [1] 25643 0

Funding & Sponsors
Funding source category [1] 314172 0
Charities/Societies/Foundations
Name [1] 314172 0
Massey Foundation
Country [1] 314172 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Research Office
Massey University
Palmerston North 4474
Country
New Zealand
Secondary sponsor category [1] 316220 0
None
Name [1] 316220 0
Address [1] 316220 0
Country [1] 316220 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313303 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 313303 0
Ethics committee country [1] 313303 0
New Zealand
Date submitted for ethics approval [1] 313303 0
19/07/2023
Approval date [1] 313303 0
Ethics approval number [1] 313303 0

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

Contacts
Principal investigator
Name 127662 0
A/Prof Emma Febvre-Richards
Address 127662 0
Whiti o Rehua School of Art
College of Creative Arts
Massey University Wellington
Wallace Street
Wellington 6021
Country 127662 0
New Zealand
Phone 127662 0
+64 212544088
Fax 127662 0
Email 127662 0
[email protected]
Contact person for public queries
Name 127663 0
Emma Febvre-Richards
Address 127663 0
Whiti o Rehua School of Art
College of Creative Arts
Massey University Wellington
Wallace Street
Wellington 6021
Country 127663 0
New Zealand
Phone 127663 0
+64 212544088
Fax 127663 0
Email 127663 0
[email protected]
Contact person for scientific queries
Name 127664 0
Susan Gee
Address 127664 0
Portocom A
Burwood Hospital
Private Bag 4708
Christchurch 8140
Country 127664 0
New Zealand
Phone 127664 0
+64 21 0233 3355
Fax 127664 0
Email 127664 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality of participants in study on basis of informed consent


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.