Cognitive ImpairmentNCT03551483

ArtontheBrain: An Inclusive Evidence-based Cognitive Health App for Older Adults to Promote Aging at Home

A study testing ArtontheBrain and Seniors Online Victoria in people with Cognitive Impairment and Mild Cognitive Impairment, run by Baycrest at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Cognitive Impairment, Mild Cognitive Impairment, Dementia
What is being tested?: ArtontheBrain and Seniors Online Victoria
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteCanada
Study dates: 24 Jul 2018to 31 Mar 2019
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 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

60 years of age and older.
Having normal or corrected to normal vision.
Self-reported proficiency in English.
Compliance with treatment, over the specified period of 6-weeks.
Having experienced:
Age-normal cognitive decline defined as having a Montreal Cognitive Assessment (MoCA) score ≥23 with no functional impairment in Instrumental Activities of Daily Living (iADLs), and no subjective memory complaint;

Show all 9Show fewer

MCI as defined as having a MoCA score ≤26 with no significant functional impairment in iADLs (e.g., no more than one iADL domain compromised), and report of memory decline by self or family member; or health professional.
Early dementia as defined as MoCA score ≤23 with significant functional impairment in more than one iADLs domain.
Having access to a computer (e.g., desktop, laptop, tablet) and internet.

Who cannot join

Significant vision loss (low vision accepted).
Non-fluent in English.
Major psychiatric disorder.
Neurological disorder causing aphasia or causing severe dementia.
Motor limitations that prevent independent use of computer technology.
Current history of substance abuse.
No access to a computer (e.g., desktop, laptop, tablet) or internet.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Baycrest Health Sciences
Toronto, Ontario, M6A 2E1

Other trials in Canada

About this study

The research proposed here will evaluate whether a web-based recreation intervention, called ArtontheBrain, has positive health benefits to older adult users. ArtontheBrain incorporates three basic activities; learning (history of the artwork), play (telling stories, solving puzzles) and socializing with other users, either in person or online. It can be used alone, with another person, or in a group. It is modeled after participatory arts-based interventions which studies have shown are associated with health benefits in older adults, such as improved sense of well-being, physical health, decreased risk of dementia, and reduced need for health services. Our study will test ArtontheBrain at research sites and health agencies in Canada, the U.S., and the U.K. with older adults with and without cognitive decline. The study will also examine how well that app can support different user play modalities and whether it can effect positive health outcomes similar to face-to-face arts interventions.

Read the detailed description

Our project seeks to validate the positive health impacts of a mobile health (mhealth) intervention, called ArtontheBrain; a web-based application (app) aimed at promoting cognitive health in older adults, aging at home, through mentally and socially engaging recreation. The app was created in response to research showing: a) older adults with chronic health conditions experience reduced access to enjoyable recreation due to various barriers (e.g., sensory loss, cognitive decline, mobility limitations, geography and low mood); and b) participatory arts-based recreation is associated with health benefits in seniors (e.g., enhanced well-being, improved physical health, decreased risk of dementia, and reduced use of healthcare resources). There are limited evidence-based solutions for consumers and this clinical validation will provide information about the efficacy of ArtontheBrain in achieving positive health outcomes to guide health practitioners and older adult consumers toward proven products.

Based on quality of life (QOL) benefits for older adults, reported from participatory arts interventions, we hypothesize that engagement with ArtontheBrain will produce similar improvements in QOL in our study participants, driven by specific features of this type of intervention e.g., self-directed, flexible level of complexity, driven by the user. Secondary outcomes hypothesized for engagement with the intervention, include benefits to: active living, aspects of cognition (e.g., attention control, reasoning) and health seeking behaviours. These hypotheses are encouraged by findings from our initial pilot testing which showed improvement in self-perceived health-related QOL and reduced doctor visits in our pilot participants and established proof of principle for the ArtontheBrain with respect to positive user feedback on their experience with this recreation app.

Conditions: Cognitive Impairment, Mild Cognitive Impairment, Dementia, Age-related Cognitive Decline, Aging
Being tested: ArtontheBrain, Seniors Online Victoria
Keywords: Arts-based Intervention, Mobile Health, Online Recreation
Medical subject headings: Cognitive Dysfunction, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ArtontheBrainDevice
The ArtontheBrain intervention has three activities focused on a user selected artwork. The activities promote an in-depth analysis of the artwork and are organized into three activity categories; learn, play, and mingle. In 'learn', the options are to read and/or listen to the curatorial description of the artwork. In 'play', the options are to engage in a word search game, to engage in a visual puzzle game, or to engage in a storytelling game whereby a reminiscence or imaged story can be written. In 'mingle' the options involve social communications about the artwork that include seeing what other comments and seeing how the artwork has been rated by others. The mingle option permits the user to engage only with a select circle of users or to engage with a group of public users.
Seniors Online VictoriaDevice
The active control group will use a freely available website, which is updated daily with online games for seniors through an organization called Seniors Online Victoria (https://www.seniorsonline.vic.gov.au/services-information/games).

Study groups in NCT03551483
Study group	Role	What they receive
ArtontheBrain	Experimental	ArtontheBrain application for about 30 to 45 minutes twice per week, over 6 weeks. Receives: Device: ArtontheBrain
Seniors Online Victoria	Active comparator	Senior Online Victoria games for about 30 to 45 minutes twice per week, over 6 weeks (https://www.seniorsonline.vic.gov.au/services-information/games), after which they will participate in the ArtontheBrain intervention. Receives: Device: ArtontheBrain; Device: Seniors Online Victoria
Waitlist Control	Other	The waitlist control group will no treatment for 6 weeks, after which they will six weeks of the ArtontheBrain intervention. Receives: Device: ArtontheBrain

What is being measured

The primary outcome is the main question the study is designed to answer.

EQ-5D-5L
The EQ-5D-5L comprises five dimensions on subjectively perceived quality of life in areas of: mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression. Participants report on a five-point scale whether they have no problems (1), slight problems (2), moderate problems (3), severe problems (4), or extreme problems (5). Then, using a visual analog scale from 0 to 100, individuals are asked to assess their momentary health state (100 indicating the best health state and 0 indicating the worst health state they can imagine).
Measured: Change from baseline quality of life at 6 week
Short Warwick-Edinburg Mental Well-Being Scale (WEMWBS)
The Short Warwick-Edinburg Mental Well-Being Scale (WEMWBS) is a 7-item scale designed to measure mental well-being over the previous two weeks. Each statement is positively phrased and measured along a 5-point Likert scale ranging from 1(i.e., never) to 5 (i.e., always). Questions include: "I've been feeling optimistic about the future"; "I've been dealing with problems well"; "I've been able to make up my mind about things".
Measured: Change from baseline mental wellbeing at 6 weeks
Short-Form Health Survey (SF-36)
The Short-Form Health Survey (SF-36) is composed of 36-items that measure health across eight domains including physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/ fatigue, emotional well-being, social functioning, pain and general health.
Measured: Change from baseline SF-36 score at 6 week
Stanford Health Care Utilization
The Stanford Chronic Disease Questionnaire Medical Care section evaluates individuals of health care utilization occurring in the previous six months. It comprises 4 items of three types of health care utilization: physician visits, emergency room visits, and hospitalization.
Measured: Change from baseline health care utilization at 6 week

Secondary outcomes (8)

Physical Activity Scale in the Elderly
The Physical Activity Scale for the Elderly (PASE) is a self-report measure of physical activity in older adults. The PASE comprises 10 items of leisure, household, and occupational activities occurring over the previous seven days. Items on the PASE are scored by multiplying the time spent (i.e., hours per week) or participation (i.e., yes or no) with empirically derived weights. Higher scores indicate higher levels of physical activity.
Measured: Change from baseline physical activity at 6 weeks
Social Engagement Survey
The Social Engagement Survey evaluates an individual's level of social engagement by their social network size, social activities and social support. In the first section, social network size is measured by asking participants to list the names of people in their lives who meet the following criteria: 1) someone with whom you feel close and can talk about personal matters; and 2) someone you have contact with at least once per month. The next section comprises 6-items of social activities measured along a 5-point Likert scale ranging from 1 (i.e., once a year or less) to 5 (i.e., every day or nearly every day) and participants are to report whether they have engaged in that activity in the past year. In the last section, participants are to respond along a 7-point Likert scale ranging from 1 (i.e., very strongly disagree) to 7 (i.e., very strongly agree) on 4-items pertaining to social support.
Measured: Change from baseline social engagement at 6 weeks
Alternative Uses Task
The Alternative Uses Task was designed to evaluate divergent thinking abilities by asking participants to generate as many uses as possible for a given item within the span of one minute. The following six items will be selected from: eyeglasses, shoes, keys, button, wooden pencil and automobile tire. Participant's responses will be recorded and scored for standard measures of divergent thinking including: fluency, flexibility, appropriateness, elaboration and originality
Measured: Change from baseline score at 6 weeks
Digit Span Test
The Forward and Backward Digit Span subtests will be used in the present study as they are associated with central executive functioning in older adults, and with arts-related competence and training. In the forward span subtest, the experimenter will read out a sequence of numbers at the rate of 1 digit/s and the participant will be instructed to recall the numbers in the same order. In the backward span sub test, the participant will recall the numbers in reverse order.
Measured: Change from baseline score at 6 weeks
Means-End Problem Solving
The Means-End Problem Solving (MEPS) test is a standardized measure comprising 10 vignettes, each with a social problem. The participants are given the beginning of the problem and the end of the problem and are asked to describe in detail the middle part of the story out loud. Participants are given as much time as they may need to fully describe their solutions and a general probe is given after each solution described (e.g., Can you think of anything else that you would like to add to this story?) to ensure all details are described and recorded.
Measured: Change from baseline score at 6 weeks
Art Engagement Survey
Engagement in arts-related activities occurring in the previous year will be assessed using the Arts Engagement Survey. Briefly, the survey quantifies art engagement by asking participants questions about participation, learning, work/ volunteering and arts-related membership. For each item, participants are asked whether or not they engaged in that event, and if so, approximately how many days or how many hours they spent engaging in that activity or event.
Measured: Change in baseline score at 6 weeks
Life Space Questionnaire (LSQ)
The Life Space Questionnaire (LSQ) is a brief survey that asks participants to reflect on the extent of their range of travel within and outside the home occurring in the previous three days. It comprises nine items with each item addressing a specific life-space zone. The LSQ is a valid and reliable measure that is useful for establishing the spatial extent for mobility among older adults.
Measured: Change in baseline score at 6 weeks
Autobiographical Interview
The Autobiographical Interview was designed to assess autobiographical memory using a text- based analysis of transcribed protocols. Participants are asked to provide a detailed description of a significant personal event, for example, from early childhood, teenage years, early adulthood, and the past year. Each memory is assessed across free recall, general probe, and specific probe conditions
Measured: Change in baseline score at 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jul 201831 Mar 2019

First posted11 Jun 2018
Study start24 Jul 2018
Primary completion31 Mar 2019 (estimated)
Study completion31 Mar 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Cognitive ImpairmentStudies 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: Participant
Enrolment: 110 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03551483
Sponsor's protocol ID: #17-49
Status last verified: Jan 2019
First submitted: 25 May 2018
Last updated: 27 Feb 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Noice T, Noice H, Kramer AF. Participatory arts for older adults: a review of benefits and challenges. Gerontologist. 2014 Oct;54(5):741-53. doi: 10.1093/geront/gnt138. Epub 2013 Dec 11.
PubMed 24336875
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PubMed 21479777
Stewart-Brown S, Tennant A, Tennant R, Platt S, Parkinson J, Weich S. Internal construct validity of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS): a Rasch analysis using data from the Scottish Health Education Population Survey. Health Qual Life Outcomes. 2009 Feb 19;7:15. doi: 10.1186/1477-7525-7-15.
PubMed 19228398
Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
PubMed 18042300
Lyons RA, Perry HM, Littlepage BN. Evidence for the validity of the Short-form 36 Questionnaire (SF-36) in an elderly population. Age Ageing. 1994 May;23(3):182-4. doi: 10.1093/ageing/23.3.182.
PubMed 8085500
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PubMed 1593914
Davies C, Knuiman M, Rosenberg M. The art of being mentally healthy: a study to quantify the relationship between recreational arts engagement and mental well-being in the general population. BMC Public Health. 2016 Jan 5;16:15. doi: 10.1186/s12889-015-2672-7.
PubMed 26733272
Washburn RA, McAuley E, Katula J, Mihalko SL, Boileau RA. The physical activity scale for the elderly (PASE): evidence for validity. J Clin Epidemiol. 1999 Jul;52(7):643-51. doi: 10.1016/s0895-4356(99)00049-9.
PubMed 10391658
Washburn RA, Smith KW, Jette AM, Janney CA. The Physical Activity Scale for the Elderly (PASE): development and evaluation. J Clin Epidemiol. 1993 Feb;46(2):153-62. doi: 10.1016/0895-4356(93)90053-4.
PubMed 8437031
Fan J, McCandliss BD, Sommer T, Raz A, Posner MI. Testing the efficiency and independence of attentional networks. J Cogn Neurosci. 2002 Apr 1;14(3):340-7. doi: 10.1162/089892902317361886.
PubMed 11970796
Levine B, Svoboda E, Hay JF, Winocur G, Moscovitch M. Aging and autobiographical memory: dissociating episodic from semantic retrieval. Psychol Aging. 2002 Dec;17(4):677-89.
PubMed 12507363
Kessels RP, van Zandvoort MJ, Postma A, Kappelle LJ, de Haan EH. The Corsi Block-Tapping Task: standardization and normative data. Appl Neuropsychol. 2000;7(4):252-8. doi: 10.1207/S15324826AN0704_8.
PubMed 11296689
Hester RL, Kinsella GJ, Ong B. Effect of age on forward and backward span tasks. J Int Neuropsychol Soc. 2004 Jul;10(4):475-81. doi: 10.1017/S1355617704104037.
PubMed 15327726
MEDNICK SA. The associative basis of the creative process. Psychol Rev. 1962 May;69:220-32. doi: 10.1037/h0048850. No abstract available.
PubMed 14472013
Murphy KJ, Troyer AK, Levine B, Moscovitch M. Episodic, but not semantic, autobiographical memory is reduced in amnestic mild cognitive impairment. Neuropsychologia. 2008 Nov;46(13):3116-23. doi: 10.1016/j.neuropsychologia.2008.07.004. Epub 2008 Jul 12.
PubMed 18675285

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ArtontheBrain: An Inclusive Evidence-based Cognitive Health App for Older Adults to Promote Aging at Home
ClinicalTrials.gov ID: NCT03551483
Acronym / sponsor ID: #17-49
Conditions: Cognitive Impairment, Mild Cognitive Impairment, Dementia, Age-related Cognitive Decline, Aging
Keywords: Arts-based Intervention, Mobile Health, Online Recreation
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 110 participants (estimated)
Lead sponsor: BaycrestUniversity, hospital or other
Collaborators: University of Calgary, Sheridan College
Study start: 24 Jul 2018 (actual)
Primary completion: 31 Mar 2019 (estimated)
Study completion: 31 Mar 2019 (estimated)
First posted: 11 Jun 2018 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
ArtontheBrain	Experimental	Device: ArtontheBrainArtontheBrain application for about 30 to 45 minutes twice per week, over 6 weeks.
Seniors Online Victoria	Active comparator	Device: ArtontheBrain, Device: Seniors Online VictoriaSenior Online Victoria games for about 30 to 45 minutes twice per week, over 6 weeks (https://www.seniorsonline.vic.gov.au/services-information/games), after which they will participate in the ArtontheBrain intervention.
Waitlist Control	Other	Device: ArtontheBrainThe waitlist control group will no treatment for 6 weeks, after which they will six weeks of the ArtontheBrain intervention.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

60 years of age and older.
Having normal or corrected to normal vision.
Self-reported proficiency in English.
Compliance with treatment, over the specified period of 6-weeks.
Having experienced:

Key exclusion criteria (7 listed)

Significant vision loss (low vision accepted).
Non-fluent in English.
Major psychiatric disorder.
Neurological disorder causing aphasia or causing severe dementia.
Motor limitations that prevent independent use of computer technology.

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
ArtontheBrainThe ArtontheBrain intervention has three activities focused on a user selected artwork. The activities promote an in-depth analysis of the artwork and are organized into three activity categories; learn, play, and mingle. In 'learn', the options are to read and/or listen to the curatorial description of the artwork. In 'play', the options are to engage in a word search game, to engage in a visual puzzle game, or to engage in a storytelling game whereby a reminiscence or imaged story can be written. In 'mingle' the options involve social communications about the artwork that include seeing what other comments and seeing how the artwork has been rated by others. The mingle option permits the user to engage only with a select circle of users or to engage with a group of public users.	Device	ArtontheBrain, Seniors Online Victoria, Waitlist Control
Seniors Online VictoriaThe active control group will use a freely available website, which is updated daily with online games for seniors through an organization called Seniors Online Victoria (https://www.seniorsonline.vic.gov.au/services-information/games).	Device	Seniors Online Victoria

Primary outcome

EQ-5D-5L
Time frame: Change from baseline quality of life at 6 week
The EQ-5D-5L comprises five dimensions on subjectively perceived quality of life in areas of: mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression. Participants report on a five-point scale whether they have no problems (1), slight problems (2), moderate problems (3), severe problems (4), or extreme problems (5). Then, using a visual analog scale from 0 to 100, individuals are asked to assess their momentary health state (100 indicating the best health state and 0 indicating the worst health state they can imagine).
Short Warwick-Edinburg Mental Well-Being Scale (WEMWBS)
Time frame: Change from baseline mental wellbeing at 6 weeks
The Short Warwick-Edinburg Mental Well-Being Scale (WEMWBS) is a 7-item scale designed to measure mental well-being over the previous two weeks. Each statement is positively phrased and measured along a 5-point Likert scale ranging from 1(i.e., never) to 5 (i.e., always). Questions include: "I've been feeling optimistic about the future"; "I've been dealing with problems well"; "I've been able to make up my mind about things".
Short-Form Health Survey (SF-36)
Time frame: Change from baseline SF-36 score at 6 week
The Short-Form Health Survey (SF-36) is composed of 36-items that measure health across eight domains including physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/ fatigue, emotional well-being, social functioning, pain and general health.
Stanford Health Care Utilization
Time frame: Change from baseline health care utilization at 6 week
The Stanford Chronic Disease Questionnaire Medical Care section evaluates individuals of health care utilization occurring in the previous six months. It comprises 4 items of three types of health care utilization: physician visits, emergency room visits, and hospitalization.

8 secondary outcomes

Physical Activity Scale in the Elderly
Time frame: Change from baseline physical activity at 6 weeks
Social Engagement Survey
Time frame: Change from baseline social engagement at 6 weeks
Alternative Uses Task
Time frame: Change from baseline score at 6 weeks
Digit Span Test
Time frame: Change from baseline score at 6 weeks
Means-End Problem Solving
Time frame: Change from baseline score at 6 weeks
Art Engagement Survey
Time frame: Change in baseline score at 6 weeks
Life Space Questionnaire (LSQ)
Time frame: Change in baseline score at 6 weeks
Autobiographical Interview
Time frame: Change in baseline score at 6 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
Background: PubMed 24336875Noice T, Noice H, Kramer AF. Participatory arts for older adults: a review of benefits and challenges. Gerontologist. 2014 Oct;54(5):741-53. doi: 10.1093/geront/gnt138. Epub 2013 Dec 11.
Background: PubMed 21479777Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
Background: PubMed 19228398Stewart-Brown S, Tennant A, Tennant R, Platt S, Parkinson J, Weich S. Internal construct validity of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS): a Rasch analysis using data from the Scottish Health Education Population Survey. Health Qual Life Outcomes. 2009 Feb 19;7:15. doi: 10.1186/1477-7525-7-15.
Background: PubMed 18042300Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
Background: PubMed 8085500Lyons RA, Perry HM, Littlepage BN. Evidence for the validity of the Short-form 36 Questionnaire (SF-36) in an elderly population. Age Ageing. 1994 May;23(3):182-4. doi: 10.1093/ageing/23.3.182.
Background: PubMed 1593914Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
Background: PubMed 26733272Davies C, Knuiman M, Rosenberg M. The art of being mentally healthy: a study to quantify the relationship between recreational arts engagement and mental well-being in the general population. BMC Public Health. 2016 Jan 5;16:15. doi: 10.1186/s12889-015-2672-7.
Background: PubMed 10391658Washburn RA, McAuley E, Katula J, Mihalko SL, Boileau RA. The physical activity scale for the elderly (PASE): evidence for validity. J Clin Epidemiol. 1999 Jul;52(7):643-51. doi: 10.1016/s0895-4356(99)00049-9.
Background: PubMed 8437031Washburn RA, Smith KW, Jette AM, Janney CA. The Physical Activity Scale for the Elderly (PASE): development and evaluation. J Clin Epidemiol. 1993 Feb;46(2):153-62. doi: 10.1016/0895-4356(93)90053-4.
Background: PubMed 11970796Fan J, McCandliss BD, Sommer T, Raz A, Posner MI. Testing the efficiency and independence of attentional networks. J Cogn Neurosci. 2002 Apr 1;14(3):340-7. doi: 10.1162/089892902317361886.
Background: PubMed 12507363Levine B, Svoboda E, Hay JF, Winocur G, Moscovitch M. Aging and autobiographical memory: dissociating episodic from semantic retrieval. Psychol Aging. 2002 Dec;17(4):677-89.
Background: PubMed 11296689Kessels RP, van Zandvoort MJ, Postma A, Kappelle LJ, de Haan EH. The Corsi Block-Tapping Task: standardization and normative data. Appl Neuropsychol. 2000;7(4):252-8. doi: 10.1207/S15324826AN0704_8.

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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.

Kelly Murphy, Ph.D principal investigator

Baycrest Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ArtontheBrain and Seniors Online Victoria in people with Cognitive Impairment and Mild Cognitive Impairment, run by Baycrest 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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Feb 2019. 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?

Results are not available in the source record.

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?

EQ-5D-5L (time frame: Change from baseline quality of life at 6 week). The study lists 4 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 NCT03551483, which also lists 21 linked publications.

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 27 Feb 2019.