DementiaNCT02432222
Effects of Visual Arts Training on Dementia
A study testing Visual Arts Training and Music Training in people with Dementia and Alzheimer Disease, run by York University.
Trial summary
The study will use a randomized controlled trial to test the efficacy of two interventions (visual arts and music) for individuals with dementia, focusing on dementia of the Alzheimer's type (DAT). Interventions will be run for 10 weeks in dementia day centers and/or retirement residences. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Alzheimer Disease
- What is being tested?
- Visual Arts Training and Music Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Dec 2015
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- dementia
Who cannot join
- known comorbid cognitive or neurological impairments
About this study
The study will use a randomized controlled trial to test the efficacy of two interventions (visual arts and music) for individuals with dementia, focusing on dementia of the Alzheimer's type (DAT). Interventions will be run for 10 weeks in dementia day centers and/or retirement residences. Participants will be tested before and after the intervention on a battery of cognitive, affective, and behavioural measures. They will be compared to a waitlist control group who don't receive the intervention.
The purpose of our research is twofold: treatment of symptoms and improved quality of life during disease progression in dementia. For the primary aim, the investigators are examining the potential of arts interventions on declining functions in dementia (memory, mood, and behavior) to investigate potential treatment effects. Secondly, quality of life will be measured, with the aim of looking beyond disease progression to contribute to an overall positive patient experience. Research has indicated the need for non-pharmacological treatments to be used as a first line of action against dementia symptoms and development. While, in best practice, pharmacological treatments should be used as a second-line approach.
Note: Music intervention dropped prior to study initiation.
Read the detailed description
Participants
Older adults age 65 and older, both males and females, with normal or corrected vision and hearing. Participants will require a diagnosis of dementia, with no other known comorbid cognitive or neurological impairments.
Participants will be randomly allocated to one of three groups
- Visual arts intervention group
- Music intervention group
- Waitlist control group (receiving the intervention after the completion of both testing sessions).
Data analysis
- Mixed 2x3 analysis of variance (ANOVA) for each construct, with within-subject factor of time (pre-intervention and post-intervention) and between-subject factor of group (visual arts, music, control).
- Test for confounding effects of background factors (socioeconomic status, education level, gender, activity participation).
- Mediation analyses for effects of mood on cognition and behaviour.
Procedure
The present study is a randomized controlled trial assessing three groups of dementia patients: a visual art group, a music group, and a non-art waitlist control group. Randomized control trials are needed in dementia research because few experimental studies exist to support that training has a causal influence on dementia related decline. Older adults with dementia will be allocated to either a visual art group, music group, or waitlist control group. Using two arts forms enables us to have active control groups to examine the specificity of observed effects.
To address inconsistencies and methodological issues in existing results, the current study will use rigorous experimental control, such as allocation concealment, adequate sample size, and tester blinding. Based on a power calculation using effect sizes from previous studies, each group will have sixty participants for an adequately powered sample. Participants will be recruited by contacting activity administrators at dementia retirement residences and day programs. Attention has and will be taken to prevent attrition, such as tailoring interventions towards participants' needs and capacities, and by involving families and caregivers in the research. Furthermore, the intervention and assessments will be conducted at the participant's respective care facility. Currently, the investigators have an established partnership with day dementia programs in the Toronto area, and will be negotiating agreements to work with other senior retirement residences and day programs. Recruiting from multiple locations and randomly assigning participants to experimental or control groups will help with generalizability of results.
Following previous studies, the art interventions will take place over ten weeks (one hour per day, two days per week). The visual art course will be a drawing course focusing on basic visual art concepts (such as shape and contrast) and the music course will be a singing and instrumental course focusing on basic music concepts (such as rhythm and melody). Defining training elements will delineate the specific effects of different activities on cognition, a poorly explored area in previous studies. The visual arts and music courses will be taught by the study's graduate student investigators (Annalise D'Souza and Katherine Matthews). Both teachers have experience and accreditations in their respective art.
Before and after both courses, all participants (wait-list control group included) will complete multiple assessment tasks. Data will be analyzed using mixed analyses of variance to compare performance for each participant at both testing sessions, and between groups. The pre-tests will occur one to two weeks before the beginning of the arts courses, and the post-tests will occur during the two weeks after the art courses are finished. Testing will occur over a two day period, for one hour per day to accommodate participants attention span and cognitive load. All tasks have been selected for their reliability, validity, and their suitability to the population at hand. To investigate specific influences of each art, separate visual and auditory/verbal tests will be used for each measure. Testing and courses will begin in early 2015, and will be run multiple times at different locations to reach the targeted sample size, with expected start dates in April, September, and January. Participant recruitment for these courses will begin in April and continue until December. Based on previous discussions with dementia day programs, and the attrition and admission rates of these programs, attaining sixty participants per group by December will be possible if the investigators continue recruiting from multiple day programs and retirement residences.
The participants' involvement in the study is completely voluntary and the participant and their caregiver (if substitute consent is required) may choose to stop their participation at any time. In the event the participant withdraws from the study all associated collected data will be immediately destroyed wherever possible. All information the participant supplies during the study will be held in confidence. Confidentiality will be provided to the fullest extent possible by law.
Hypotheses
Predictions are outlined in the hypotheses below:
- Visual art and music training will offset some of the decline in cognitive functions (working memory, long-term memory, selective attention, dual-tasking, and task switching).
- Effects of visual art will be greater on visual measures of cognition and effects of music will be greater on auditory measures
- Visual art and music training will improve mood and lessen problematic behavior.
- Visual art and music training will improve overall quality of life.
- Mood will mediate some of the changes in cognition and behaviour
Background
The present study focuses on non-pharmacological art interventions for persons with Alzheimer's disease and related dementias. Arts interventions will be designed and implemented to investigate the effects of arts training on disease symptomology and overall quality of life for persons with dementia. Dementia can be characterized by declining cognitive functions, accompanied by a loss of daily functioning (DSM-IV, 2000), with a range of cognitive, behavioural, and psychological deficits for different types of dementia.
The study will use a randomized controlled trial to test efficacy of two arts interventions. Arts and dementia experts will guide intervention design to ensure that programs are powerful and controlled. With the aims of reliability and applicability, interventions will be created that can be tested by future researchers and applied by real-world practitioners. Effects will be evaluated with a broad range of measures (affective, cognitive, and behavioural. The proposed study is significant for two reasons. First, it addresses a repeatedly highlighted need for non-pharmacological interventions in treating dementia. Second, it looks beyond disease treatment alone by looking to also improve overall quality of life in patients with dementia.
Non-pharmacological interventions offer great potential for mental improvement, but further experimental research is needed before efficacy is established. A large evidence base demonstrates a cognitive benefit of arts on healthy older adults. It is uncertain however, whether such findings also apply to individuals with dementia. A few preliminary studies indicate similar benefits can be found, but not all studies have reported cognitive improvements following arts interventions in this patient population. In addition, prospective studies indicate a link between dementia and cognitively stimulating activities such as the arts. For example, it has been supported that older adults who participate in more stimulating activities also display fewer incidences of dementia and Alzheimer's disease.
Research suggests that non-pharmacological treatments should be used as a first line of action against dementia, while pharmacological treatments should serve as a second-line approach. While non-pharmacological treatments have indicated remedial effects, there is a need for reliably conducted experiments to establish efficacy. Art recreation is easy to administer, inexpensive and non-time consuming. Unlike the majority of current pharmacological treatments, it is a noninvasive and pleasurable activity, and maintains the personhood of the individual with dementia.
Note: Music intervention dropped prior to study initiation, due to insufficient participant recruitment.
- Conditions
- Dementia, Alzheimer Disease
- Being tested
- Visual Arts Training, Music Training
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Arts TrainingBehavioural
Visual arts training
Music TrainingBehavioural
Music training
| Study group | Role | What they receive |
|---|---|---|
| Music Training | Experimental | Music training Receives: Behavioral: Music Training |
| Visual Arts Training | Experimental | Visual arts training Receives: Behavioral: Visual Arts Training |
| Control | No intervention | Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MOCA, change measure)
Designed by Nasreddine (2005) for overall cognitive assessment
Measured: baseline and 8 weeks
Working memory (change measure)
Visual (body part pointing test, Stopford et al, 2010), auditory (digit span test, Weschler, 2008)
Measured: baseline and 8 weeks
Rey-Osterreith test of long-term memory (change measure)
Rey-Osterreith Complex Figure Recognition, Rey-Osterreith Figure Copy, Rey-Osterreith verbal task (Osterreith, 1944; Schmidt, 1996)
Measured: baseline and 8 weeks
Trails test of set-shifting (change measure)
Measure of set-shifting/task switching
Measured: baseline and 8 weeks
Dual task for visual and auditory search (change measure)
designed by Baddeley (2001)
Measured: baseline and 8 weeks
Secondary outcomes (3)
Behavioural psychiatric peformance (time-to-event measure)
Neuropsychiatric Inventory (NPI; Cummings, 2009)
Measured: from date of randomization upto 8 weeks
Quality of Life (change measure)
Questionnaire on well-being (Kerner, Patterson, Grant, \& Kaplan, 1998) to be filled out by caregivers
Measured: baseline and 8 weeks
Visual analog mood scale
Measure of mood designed by Stern et al (2010) and Temple et al (2004)
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melody Wiseheart, York University
- Investigators
- Melody Wiseheart, PhD, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432222
- Sponsor's protocol ID
- YorkU-AD1
- Status last verified
- Jul 2016
- First submitted
- 1 Apr 2015
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Visual Arts Training on Dementia
- ClinicalTrials.gov ID
- NCT02432222
- Acronym / sponsor ID
- YorkU-AD1
- Conditions
- Dementia, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 May 2015 (estimated)
- 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 study will use a randomized controlled trial to test the efficacy of two interventions (visual arts and music) for individuals with dementia, focusing on dementia of the Alzheimer's type (DAT). Interventions will be run for 10 weeks in dementia day centers and/or retirement residences. Participants will be tested before and after the intervention on a battery of cognitive, affective, and behavioural measures. They will be compared to a waitlist control group who don't receive the intervention.
The purpose of our research is twofold: treatment of symptoms and improved quality of life during disease progression in dementia. For the primary aim, the investigators are examining the potential of arts interventions on declining functions in dementia (memory, mood, and behavior) to investigate potential treatment effects. Secondly, quality of life will be measured, with the aim of looking beyond disease progression to contribute to an overall positive patient experience. Research has indicated the need for non-pharmacological treatments to be used as a first line of action against dementia symptoms and development. While, in best practice, pharmacological treatments should be used as a second-line approach.
Note: Music intervention dropped prior to study initiation.
Detailed description
Participants
Older adults age 65 and older, both males and females, with normal or corrected vision and hearing. Participants will require a diagnosis of dementia, with no other known comorbid cognitive or neurological impairments.
Participants will be randomly allocated to one of three groups
- Visual arts intervention group
- Music intervention group
- Waitlist control group (receiving the intervention after the completion of both testing sessions).
Data analysis
- Mixed 2x3 analysis of variance (ANOVA) for each construct, with within-subject factor of time (pre-intervention and post-intervention) and between-subject factor of group (visual arts, music, control).
- Test for confounding effects of background factors (socioeconomic status, education level, gender, activity participation).
- Mediation analyses for effects of mood on cognition and behaviour.
Procedure
The present study is a randomized controlled trial assessing three groups of dementia patients: a visual art group, a music group, and a non-art waitlist control group. Randomized control trials are needed in dementia research because few experimental studies exist to support that training has a causal influence on dementia related decline. Older adults with dementia will be allocated to either a visual art group, music group, or waitlist control group. Using two arts forms enables us to have active control groups to examine the specificity of observed effects.
To address inconsistencies and methodological issues in existing results, the current study will use rigorous experimental control, such as allocation concealment, adequate sample size, and tester blinding. Based on a power calculation using effect sizes from previous studies, each group will have sixty participants for an adequately powered sample. Participants will be recruited by contacting activity administrators at dementia retirement residences and day programs. Attention has and will be taken to prevent attrition, such as tailoring interventions towards participants' needs and capacities, and by involving families and caregivers in the research. Furthermore, the intervention and assessments will be conducted at the participant's respective care facility. Currently, the investigators have an established partnership with day dementia programs in the Toronto area, and will be negotiating agreements to work with other senior retirement residences and day programs. Recruiting from multiple locations and randomly assigning participants to experimental or control groups will help with generalizability of results.
Following previous studies, the art interventions will take place over ten weeks (one hour per day, two days per week). The visual art course will be a drawing course focusing on basic visual art concepts (such as shape and contrast) and the music course will be a singing and instrumental course focusing on basic music concepts (such as rhythm and melody). Defining training elements will delineate the specific effects of different activities on cognition, a poorly explored area in previous studies. The visual arts and music courses will be taught by the study's graduate student investigators (Annalise D'Souza and Katherine Matthews). Both teachers have experience and accreditations in their respective art.
Before and after both courses, all participants (wait-list control group included) will complete multiple assessment tasks. Data will be analyzed using mixed analyses of variance to compare performance for each participant at both testing sessions, and between groups. The pre-tests will occur one to two weeks before the beginning of the arts courses, and the post-tests will occur during the two weeks after the art courses are finished. Testing will occur over a two day period, for one hour per day to accommodate participants attention span and cognitive load. All tasks have been selected for their reliability, validity, and their suitability to the population at hand. To investigate specific influences of each art, separate visual and auditory/verbal tests will be used for each measure. Testing and courses will begin in early 2015, and will be run multiple times at different locations to reach the targeted sample size, with expected start dates in April, September, and January. Participant recruitment for these courses will begin in April and continue until December. Based on previous discussions with dementia day programs, and the attrition and admission rates of these programs, attaining sixty participants per group by December will be possible if the investigators continue recruiting from multiple day programs and retirement residences.
The participants' involvement in the study is completely voluntary and the participant and their caregiver (if substitute consent is required) may choose to stop their participation at any time. In the event the participant withdraws from the study all associated collected data will be immediately destroyed wherever possible. All information the participant supplies during the study will be held in confidence. Confidentiality will be provided to the fullest extent possible by law.
Hypotheses
Predictions are outlined in the hypotheses below:
- Visual art and music training will offset some of the decline in cognitive functions (working memory, long-term memory, selective attention, dual-tasking, and task switching).
- Effects of visual art will be greater on visual measures of cognition and effects of music will be greater on auditory measures
- Visual art and music training will improve mood and lessen problematic behavior.
- Visual art and music training will improve overall quality of life.
- Mood will mediate some of the changes in cognition and behaviour
Background
The present study focuses on non-pharmacological art interventions for persons with Alzheimer's disease and related dementias. Arts interventions will be designed and implemented to investigate the effects of arts training on disease symptomology and overall quality of life for persons with dementia. Dementia can be characterized by declining cognitive functions, accompanied by a loss of daily functioning (DSM-IV, 2000), with a range of cognitive, behavioural, and psychological deficits for different types of dementia.
The study will use a randomized controlled trial to test efficacy of two arts interventions. Arts and dementia experts will guide intervention design to ensure that programs are powerful and controlled. With the aims of reliability and applicability, interventions will be created that can be tested by future researchers and applied by real-world practitioners. Effects will be evaluated with a broad range of measures (affective, cognitive, and behavioural. The proposed study is significant for two reasons. First, it addresses a repeatedly highlighted need for non-pharmacological interventions in treating dementia. Second, it looks beyond disease treatment alone by looking to also improve overall quality of life in patients with dementia.
Non-pharmacological interventions offer great potential for mental improvement, but further experimental research is needed before efficacy is established. A large evidence base demonstrates a cognitive benefit of arts on healthy older adults. It is uncertain however, whether such findings also apply to individuals with dementia. A few preliminary studies indicate similar benefits can be found, but not all studies have reported cognitive improvements following arts interventions in this patient population. In addition, prospective studies indicate a link between dementia and cognitively stimulating activities such as the arts. For example, it has been supported that older adults who participate in more stimulating activities also display fewer incidences of dementia and Alzheimer's disease.
Research suggests that non-pharmacological treatments should be used as a first line of action against dementia, while pharmacological treatments should serve as a second-line approach. While non-pharmacological treatments have indicated remedial effects, there is a need for reliably conducted experiments to establish efficacy. Art recreation is easy to administer, inexpensive and non-time consuming. Unlike the majority of current pharmacological treatments, it is a noninvasive and pleasurable activity, and maintains the personhood of the individual with dementia.
Note: Music intervention dropped prior to study initiation, due to insufficient participant recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Music Training | Experimental | Behavioral: Music TrainingMusic training |
| Visual Arts Training | Experimental | Behavioral: Visual Arts TrainingVisual arts training |
| Control | No intervention | –Waitlist control |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- dementia
Key exclusion criteria (1 listed)
- known comorbid cognitive or neurological impairments
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 TrainingVisual arts training | Behavioural | Visual Arts Training |
| Music TrainingMusic training | Behavioural | Music Training |
Primary outcome
Montreal Cognitive Assessment (MOCA, change measure)
Time frame: baseline and 8 weeks
Designed by Nasreddine (2005) for overall cognitive assessment
Working memory (change measure)
Time frame: baseline and 8 weeks
Visual (body part pointing test, Stopford et al, 2010), auditory (digit span test, Weschler, 2008)
Rey-Osterreith test of long-term memory (change measure)
Time frame: baseline and 8 weeks
Rey-Osterreith Complex Figure Recognition, Rey-Osterreith Figure Copy, Rey-Osterreith verbal task (Osterreith, 1944; Schmidt, 1996)
Trails test of set-shifting (change measure)
Time frame: baseline and 8 weeks
Measure of set-shifting/task switching
Dual task for visual and auditory search (change measure)
Time frame: baseline and 8 weeks
designed by Baddeley (2001)
3 secondary outcomes
Behavioural psychiatric peformance (time-to-event measure)
Time frame: from date of randomization upto 8 weeks
Quality of Life (change measure)
Time frame: baseline and 8 weeks
Visual analog mood scale
Time frame: baseline and 8 weeks
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 13 Jul 2016.
- 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.
Melody Wiseheart, PhD principal investigator
York University
Questions about this trial
What is this clinical trial studying?
A study testing Visual Arts Training and Music Training in people with Dementia and Alzheimer Disease, run by York University.
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 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Montreal Cognitive Assessment (MOCA, change measure) (time frame: baseline and 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2016.