- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03175822
Effects of Visual Art Training on Dementia
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Aurora, Ontario, Canada
- Alzheimer's Society of York Region
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Dementia
Exclusion Criteria:
- Inability to participate in the art training program due to physical or cognitive limitations
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Waitlist Control
|
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Experimental: Visual Arts Training
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cognition
Time Frame: baseline up to three weeks prior, and final assessment one to two weeks post-intervention
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Montreal Cognitive Assessment (MoCA; Nasreddine, 2005)
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baseline up to three weeks prior, and final assessment one to two weeks post-intervention
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Change in visual working memory
Time Frame: baseline up to three weeks prior, and final assessment one to two weeks post-intervention
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Body Part Pointing Test (Stopford et al., 2010)
|
baseline up to three weeks prior, and final assessment one to two weeks post-intervention
|
Change in auditory working memory
Time Frame: baseline up to three weeks prior, and final assessment one to two weeks post-intervention
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Digit Span (Weschler, 2008)
|
baseline up to three weeks prior, and final assessment one to two weeks post-intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YorkU-AD2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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