Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001614189p
Ethics application status
Not yet submitted
Date submitted
9/11/2019
Date registered
22/11/2019
Date last updated
22/11/2019
Date data sharing statement initially provided
22/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Meditative Drawing for People with Dementia and their Care Partners
Scientific title
MinDArT Stage 2: Pilot testing of a dual group programme based on meditative and fine motor qualities of drawing for people with dementia and their care partners
Secondary ID [1] 299757 0
Nil known
Universal Trial Number (UTN)
U1111-1243-1896
Trial acronym
MinDArt
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 315119 0
Carer stress 315129 0
Condition category
Condition code
Neurological 313438 313438 0 0
Dementias
Mental Health 313514 313514 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MinDArt, a new group programme of drawing sessions that combine the principles of maintaining fine motor skills with the meditative qualities of drawing on paper and digital tablets. MinDArt was specifically designed for people with dementia and their care partners. It comprises of eight weekly 90-minutes sessions. The programme was user-tested (and subsequently modified) with a group of eight care partners of people with dementia between July and September 2019. We are now ready to pilot test this dual care programme with a group of people with dementia and their care partners.

Each MinDArt session involves 90 minutes of exploring basic repetitive drawing gestures through different mediums such as pencils, felt tip pens, stickers, paint, sand, lengths of wool and a tailored digital drawing application on a tablet. Each session starting with a welcome and ending with a round up discussion. A document with a more detailed description of the 8 sessions is also now uploaded.

There are 8 participants and the participants are invited to give feedback on the activities being explored. In week 4 there is a pair activity of painting together.

The people with dementia will be in a room adjacent to the room being used for the care partners session.

The session will be run by a fine arts university lecturer and a dementia advisor from Dementia Wellington.

Attendance will be taken and there will be constant supervision for all activities.
Intervention code [1] 316020 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321921 0
Quality of life Alzheimer’s disease Scale (person with dementia)
Timepoint [1] 321921 0
8 weeks post enrolment
Primary outcome [2] 321922 0
Zarit Burden Interview (care partner) to assess caregiver burden
Timepoint [2] 321922 0
8 weeks post enrolement
Secondary outcome [1] 376710 0
Mini-mental state examination (person with dementia) to assess global cognition
Timepoint [1] 376710 0
8 weeks post enrolment
Secondary outcome [2] 376711 0
Rosenberg self-esteem scale (person with dementia and care partner)
Timepoint [2] 376711 0
8 weeks post enrolment
Secondary outcome [3] 376712 0
State-Trait Anxiety Inventory (person with dementia and care partner)
Timepoint [3] 376712 0
8 weeks post enrolment
Secondary outcome [4] 376713 0
Addenbrooke’s Cognitive Examination (III) (person with dementia)
Timepoint [4] 376713 0
8 weeks post enrolment
Secondary outcome [5] 376714 0
Quality of the carer-patient relationship (person with dementia and care partner)
Timepoint [5] 376714 0
8 weeks post enrolment
Secondary outcome [6] 376715 0
Connor-Davidson Resilience Scale (10-items) (care partner)
Timepoint [6] 376715 0
8 weeks post enrolment

Eligibility
Key inclusion criteria
Person with dementia:
(i) A diagnosis of Alzheimer’s disease or related dementia
(ii) A mini-mental state examination (MMSE) score between 16 and 26 out of 30
(iii) A relatively intact visuospatial function as determined by a score of 13 or above out of 16 on the Addenbrooke’s Cognitive Examination (version III) visuospatial subscale.
(iv) No significant hearing or visual impairment
(v) Capacity to provide informed consent

Care Partner:
(i) At least once weekly contact with the person with dementia
(ii) No significant hearing or visual impairment
(iii) Provide informed consent
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Person with dementia:
(i) Care partner not available for the group programme
(ii) Physically unable to attend the group programme
(iii) Physical disability that affect participation in drawing and/or using a tablet.

Care Partner:
(i) Not available or physically able to attend the group programme
(ii) Physical disability that affect participation in drawing and/or using a tablet.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We will obtain information on the outcome measures in terms of their scores range, improvement in scores and variability in the scores.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2020
Actual
Date of last participant enrolment
Anticipated
28/02/2020
Actual
Date of last data collection
Anticipated
31/05/2020
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment outside Australia
Country [1] 22034 0
New Zealand
State/province [1] 22034 0
Wellington

Funding & Sponsors
Funding source category [1] 304224 0
Charities/Societies/Foundations
Name [1] 304224 0
The Massey University Foundation and Massey University, New Zealand
Country [1] 304224 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Whiti o Rehua School of Art
College of Creative Arts – Toi Rauwharangi
Massey University, Wellington, Aotearoa New Zealand
Te Whare Pukaka
Eastern End Block 1
63 Wallace Street, Entrance C
Wellington 6021
New Zealand
Country
New Zealand
Secondary sponsor category [1] 304472 0
None
Name [1] 304472 0
None
Address [1] 304472 0
None
Country [1] 304472 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 304685 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 304685 0
Ethics committee country [1] 304685 0
New Zealand
Date submitted for ethics approval [1] 304685 0
01/12/2019
Approval date [1] 304685 0
Ethics approval number [1] 304685 0

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

Contacts
Principal investigator
Name 97858 0
Ms Emma Febvre-Richards
Address 97858 0
Whiti o Rehua School of Art
College of Creative Arts – Toi Rauwharangi
Massey University, Wellington, Aotearoa New Zealand
Te Whare Pukaka
Eastern End Block 1
63 Wallace Street, Entrance C
Wellington 6021
Country 97858 0
New Zealand
Phone 97858 0
+64 21 254 4088
Fax 97858 0
Email 97858 0
[email protected]
Contact person for public queries
Name 97859 0
Emma Febvre-Richards
Address 97859 0
Whiti o Rehua School of Art
College of Creative Arts – Toi Rauwharangi
Massey University, Wellington, Aotearoa New Zealand
Te Whare Pukaka
Eastern End Block 1
63 Wallace Street, Entrance C
Wellington 6021
Country 97859 0
New Zealand
Phone 97859 0
+64 21 254 4088
Fax 97859 0
Email 97859 0
[email protected]
Contact person for scientific queries
Name 97860 0
Gary Cheung
Address 97860 0
Room 12.003, 12th Floor
Auckland Hospital Support Building
Park Road, Grafton
Auckland 1142
Country 97860 0
New Zealand
Phone 97860 0
+64 21 332 823
Fax 97860 0
Email 97860 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
This is a pilot project and data collected will be used to inform a larger study in the future. We are not intend to share our data because of our small sample size in this study and we don't want our participants to be at risk of being identified through data sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5601Study protocol    378700-(Uploaded-18-11-2019-17-53-55)-Study-related document.docx
5744Study protocol    378700-(Uploaded-18-11-2019-17-55-58)-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.