DementiaNCT03175822
Effects of Visual Art Training on Dementia
A study testing Visual Arts Training in people with Dementia, run by York University at 1 site in Canada.
Trial summary
The purpose of the proposed study is to better understand what benefits visual art has on reducing problematic symptoms in dementia patients, including those with Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Visual Arts Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2017to 15 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dementia
Who cannot join
- Inability to participate in the art training program due to physical or cognitive limitations
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the proposed study is to better understand what benefits visual art has on reducing problematic symptoms in dementia patients, including those with Alzheimer's disease.
Read the detailed description
Participants:
Participants will be residents, attendees and/or members of assisted living locations and/or dementia (or related) day programs. There will be two groups: an art training group and a waitlist control group.
Data Analysis:
- For primary measures, t-tests on pre-post difference scores comparing art training and waitlist groups.
- For possible confounding effects, tests for confounds related to background factors (socioeconomic status, education level, gender, activity participation).
Procedure:
A randomized controlled trial design will be utilized to assess two groups of dementia patients: an art training experimental group and a structured usual-activity waitlist control group. The experimental group will participate in a visual art training program and the waitlist control group will participate in their usual structured group activities. The waitlist control group will receive the art training program once post-testing is complete. Before, during, and/or after the art programs and/or control activities, participants will be observed and complete assessments.
- Conditions
- Dementia
- Being tested
- Visual Arts Training
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Arts TrainingBehavioural
The art training program has been designed as a drawing program and focuses on basic visual art concepts (the elements [e.g., colour and line] and principles [e.g., proportion and balance] of design). Each week has a different activity and a different focus (one activity per week focusing on one element and principle of design). Each art training program will occur one hour per day, two days per week, for eight weeks. The art training program will take place at the participants' respective dementia care location in an area separate from waitlist control participants and uninvolved clients. All art programs are free for participants.
| Study group | Role | What they receive |
|---|---|---|
| Visual Arts Training | Experimental | Visual Arts Training Receives: Behavioral: Visual Arts Training |
| Waitlist Control | No intervention | Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognition
Montreal Cognitive Assessment (MoCA; Nasreddine, 2005)
Measured: baseline up to three weeks prior, and final assessment one to two weeks post-intervention
Change in visual working memory
Body Part Pointing Test (Stopford et al., 2010)
Measured: baseline up to three weeks prior, and final assessment one to two weeks post-intervention
Change in auditory working memory
Digit Span (Weschler, 2008)
Measured: baseline up to three weeks prior, and final assessment one to two weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Sep 2017
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melody Wiseheart, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175822
- Sponsor's protocol ID
- YorkU-AD2
- Status last verified
- Jul 2018
- First submitted
- 24 May 2017
- Last updated
- 24 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Johnson KG, D'Souza AA, Wiseheart M. Art Training in Dementia: A Randomized Controlled Trial. Front Psychol. 2020 Dec 15;11:585508. doi: 10.3389/fpsyg.2020.585508. eCollection 2020.
PubMed 33384640
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Visual Art Training on Dementia
- ClinicalTrials.gov ID
- NCT03175822
- Acronym / sponsor ID
- YorkU-AD2
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the proposed study is to better understand what benefits visual art has on reducing problematic symptoms in dementia patients, including those with Alzheimer's disease.
Detailed description
Participants:
Participants will be residents, attendees and/or members of assisted living locations and/or dementia (or related) day programs. There will be two groups: an art training group and a waitlist control group.
Data Analysis:
- For primary measures, t-tests on pre-post difference scores comparing art training and waitlist groups.
- For possible confounding effects, tests for confounds related to background factors (socioeconomic status, education level, gender, activity participation).
Procedure:
A randomized controlled trial design will be utilized to assess two groups of dementia patients: an art training experimental group and a structured usual-activity waitlist control group. The experimental group will participate in a visual art training program and the waitlist control group will participate in their usual structured group activities. The waitlist control group will receive the art training program once post-testing is complete. Before, during, and/or after the art programs and/or control activities, participants will be observed and complete assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual Arts Training | Experimental | Behavioral: Visual Arts TrainingVisual Arts Training |
| Waitlist Control | No intervention | –Waitlist Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dementia
Key exclusion criteria (1 listed)
- Inability to participate in the art training program due to physical or cognitive limitations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual Arts TrainingThe art training program has been designed as a drawing program and focuses on basic visual art concepts (the elements [e.g., colour and line] and principles [e.g., proportion and balance] of design). Each week has a different activity and a different focus (one activity per week focusing on one element and principle of design). Each art training program will occur one hour per day, two days per week, for eight weeks. The art training program will take place at the participants' respective dementia care location in an area separate from waitlist control participants and uninvolved clients. All art programs are free for participants. | Behavioural | Visual Arts Training |
Primary outcome
Change in cognition
Time frame: baseline up to three weeks prior, and final assessment one to two weeks post-intervention
Montreal Cognitive Assessment (MoCA; Nasreddine, 2005)
Change in visual working memory
Time frame: baseline up to three weeks prior, and final assessment one to two weeks post-intervention
Body Part Pointing Test (Stopford et al., 2010)
Change in auditory working memory
Time frame: baseline up to three weeks prior, and final assessment one to two weeks post-intervention
Digit Span (Weschler, 2008)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Derived from this study: PubMed 33384640Johnson KG, D'Souza AA, Wiseheart M. Art Training in Dementia: A Randomized Controlled Trial. Front Psychol. 2020 Dec 15;11:585508. doi: 10.3389/fpsyg.2020.585508. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Arts Training in people with Dementia, run by York University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognition (time frame: baseline up to three weeks prior, and final assessment one to two weeks post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03175822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.