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Trial registered on ANZCTR


Registration number
ACTRN12616000100493
Ethics application status
Approved
Date submitted
28/01/2016
Date registered
1/02/2016
Date last updated
8/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
ART & DEMENTIA: Does an art program enhance wellbeing and markers of neuroplasticity in people with dementia?
Scientific title
A randomised controlled trial to assess whether a 10 week combined gallery-facilitated and at-home art program, ‘Art & Dementia’, can affect changes in neuropsychological markers of visuospatial functioning, as well as improvements in ratings of quality of life, mood and carer burden, in older adults with dementia.
Secondary ID [1] 288393 0
Nil
Universal Trial Number (UTN)
U1111-1178-8264
Trial acronym
ART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 297399 0
Cognitive Decline 297400 0
Condition category
Condition code
Mental Health 297589 297589 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 297591 297591 0 0
Dementias
Neurological 297639 297639 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention of interest for this trial is a 10-week gallery-facilitated community art program, ‘Art & Dementia’, developed by the Museum of Contemporary Art in conjunction with Alzheimer's Australia. Those participants assigned to the art program intervention will complete 5 fortnightly face-to-face gallery-facilitated sessions (approx 2 hours per session) at the Museum of Contemporary Art (MCA), alternated with 5 fortnightly at-home sessions (approx 1 hour per session), over a 10-week period. At-home sessions will be directed by the participant via at-home packs provided by the MCA containing creative and discussion exercises. Gallery-facilitated sessions will be administered by an art educator and gallery access staff, and will occur in small groups. Sessions will include both art viewing/education, and creating art with mixed medias. Adherence to the intervention will be monitored by MCA's program coordinator via gallery attendance logs, as well as self-monitored by fortnightly art diaries provided by the MCA.
Intervention code [1] 293702 0
Other interventions
Comparator / control treatment
Those randomised to 'waitlist control' condition will not participate in the art program immediately, rather will be instructed to continue their 'activities as usual' for the 10 week period. Following completion of follow-up assessment and research involvement they will be invited to attend the next available art program intake.
Control group
Active

Outcomes
Primary outcome [1] 297141 0
Memory performance as measured by the Rey Complex Figure Test.
Timepoint [1] 297141 0
Baseline, and directly post-intervention (within two weeks of completing the intervention).
Primary outcome [2] 297142 0
Visuospatial skills, visuomotor functioning, and processing speed as measured by Clock-Drawing Task.
Timepoint [2] 297142 0
Baseline, and post-intervention (within two weeks of completing the intervention).
Primary outcome [3] 297143 0
Change in self-reported measure of quality of life as measured by World Health Organization - Quality of Life, and Quality of Life – Alzheimer’s Disease.
Timepoint [3] 297143 0
Baseline, and directly post-intervention (within two weeks of completing the intervention).
Secondary outcome [1] 320149 0
Change in depressive symptoms as determined by the Geriatric Depression Scale.
Timepoint [1] 320149 0
Baseline, and directly post-intervention (within two weeks of completing the intervention).
Secondary outcome [2] 320150 0
Objective change in self-report carer burden as determined by the Zarit Burden Interview.
Timepoint [2] 320150 0
Baseline, and directly post-intervention (within two weeks of completing the intervention).
Secondary outcome [3] 320151 0
Change in score on the Flourishing Scale.
Timepoint [3] 320151 0
Baseline, and directly post-intervention (within two weeks of completing the intervention).
Secondary outcome [4] 320152 0
Improved knowledge of art-work in the MCA galleries as measured by an evaluation questionnaire.
Timepoint [4] 320152 0
Directly post-intervention (within two weeks of completing the intervention). Questionnaire designed specifically for this study.
Secondary outcome [5] 320307 0
Change in score on The Warwick-Edinburgh Mental Well-being Scale (WEMWBS).
Timepoint [5] 320307 0
Baseline, and directly post-intervention (within two weeks of completing the intervention).
Secondary outcome [6] 320308 0
Change in carer quality of life as determined by the WHO-QOL-Brief.
Timepoint [6] 320308 0
Baseline, and directly post-intervention (within two weeks of completing the intervention).
Secondary outcome [7] 320309 0
Carer-reported functional improvement as per the Naismith & Mowszowski Functional tool.
Timepoint [7] 320309 0
Baseline, and directly post-intervention (within two weeks of completing the intervention).
Secondary outcome [8] 320310 0
Objective verbal learning as per the Hopkins Verbal Learning Test.
*NB: primary outcome measure
Timepoint [8] 320310 0
Baseline, and directly post-intervention (within two weeks of completing the intervention).
Secondary outcome [9] 320311 0
Visuospatial skills, visuomotor functioning, and processing speed as measured by Rey Complex Figure Test.
*NB: primary outcome measure
Timepoint [9] 320311 0
Baseline, and directly post-intervention (within two weeks of completing the intervention).
Secondary outcome [10] 320312 0
Visuospatial skills, visuomotor functioning, and processing speed as measured by Trail Making Test Parts A & B.
*NB: primary outcome measure
Timepoint [10] 320312 0
Baseline, and directly post-intervention (within two weeks of completing the intervention).
Secondary outcome [11] 320315 0
Satisfaction with the Art & Dementia Program as measured by an evaluation questionnaire.
Timepoint [11] 320315 0
Directly post-intervention (within two weeks of completing the intervention). Questionnaire designed specifically for this study.

Eligibility
Key inclusion criteria
To be eligible participants must:
*Be between 30 and 90 years of age
*Have a diagnosis of dementia
*Have capacity to participate (as assessed by a clinical neuropsychologist)
*Have a carer or family member who is willing to complete self-report questionnaires
*Be willing to attend a 10 week program at the Museum of Contemporary Art, Sydney, NSW
*Be willing to attend for follow-up assessment and do not meet any of the exclusion criteria
Minimum age
30 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they:
*Do not have English as a primary language
*Have other major neurological problems (e.g. Stroke, epilepsy, head injury)
*Have a severe mental health disorder (e.g. schizophrenia)
*Have drug or alcohol-related dementia, or are currently dependent on drugs and/or alcohol

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)
Eligible participants will be automatically randomised upon completion of consent, eligibility screening, and baseline assessments. This will be done off-site by the study coordinator (central administration). Allocation concealment will be achieved using a computerised and customised randomisation schedule. The fully itemised procedure allows for full replication and can accommodate stratification and specification of block sizes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised at the time of baseline assessment using a randomly generated number sequence allocated by a blinded researcher not involved in trial data gathering, assessments or treatment. Randomisation will be undertaken using permuted blocks and stratified by cognitive function severity, as defined by MMSE scores of equal or below 24, and above 24.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Recruitment and intervention will occur in waves.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is an exploratory study with a group where the effects are likely to be quite heterogenous and improvements expected to be relatively small, due to the disease stage. Thus, based on our previous work, we have allowed for ~10% attrition and expect a small effect size improvement in the treatment group given the profile of this particular group. However this work is novel and within this pilot study we seek to determine the actual effect size difference between groups. The outcomes of this study will be used to power a larger more rigorous randomized controlled trial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/03/2016
Actual
22/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292752 0
Charities/Societies/Foundations
Name [1] 292752 0
Vincent Fairfax Family Foundation
Country [1] 292752 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Brain and Mind Centre
94 Mallett Street
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 291480 0
None
Name [1] 291480 0
Nil
Address [1] 291480 0
None
Country [1] 291480 0
Other collaborator category [1] 278785 0
Other Collaborative groups
Name [1] 278785 0
Museum of Contemporary Art
Address [1] 278785 0
140 George Street
The Rocks NSW 2000
Country [1] 278785 0
Australia
Other collaborator category [2] 278786 0
Charities/Societies/Foundations
Name [2] 278786 0
Alzheimer's Australia NSW
Address [2] 278786 0
Macquarie Hospital
Building 21, Gibson-Denney Centre
Cnr 120 Coxs & Norton Roads
North Ryde NSW 2113
Country [2] 278786 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294238 0
University of Sydney
Ethics committee address [1] 294238 0
Level 6, Jane Foss Russell Building
University of Sydney NSW 2006
Ethics committee country [1] 294238 0
Australia
Date submitted for ethics approval [1] 294238 0
16/11/2015
Approval date [1] 294238 0
19/01/2016
Ethics approval number [1] 294238 0
2016/003

Summary
Brief summary
The study is a pilot randomised proof-of-concept trial that aims to identify potential cognitive markers by utilising a 10-week social and creative, gallery-facilitated "Art & Dementia" program to examine its relationship with memory and learning tasks in adults with dementia. Specifically, we hope to ascertain whether: a) there are clinical predictors of benefit associated with an art program, b) there is improvement in visuospatial cognitive skills associated with an art program, and c) an art program is associated with improved wellbeing and reduced carer burden. We will compare the efficacy of this program to a waitlist group.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 62990 0
Prof Sharon Naismith
Address 62990 0
Brain and Mind Centre
University of Sydney
94 Mallett Street
Camperdown NSW 2050
Country 62990 0
Australia
Phone 62990 0
+61 2 9351 0781
Fax 62990 0
+61 2 9351 0551
Email 62990 0
[email protected]
Contact person for public queries
Name 62991 0
Stacey West
Address 62991 0
Brain and Mind Centre
University of Sydney
94 Mallett Street
Camperdown NSW 2050
Country 62991 0
Australia
Phone 62991 0
+61 2 9114 4002
Fax 62991 0
+61 2 9351 0551
Email 62991 0
[email protected]
Contact person for scientific queries
Name 62992 0
Sharon Naismith
Address 62992 0
Brain and Mind Centre
University of Sydney
94 Mallett Street
Camperdown NSW 2050
Country 62992 0
Australia
Phone 62992 0
+61 2 9351 0781
Fax 62992 0
+61 2 9351 0551
Email 62992 0
[email protected]

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No Supporting Document Provided



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