NCT03551483

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 24, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

February 27, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

May 25, 2018

Last Update Submit

February 26, 2019

Conditions

Keywords

Arts-based InterventionMobile HealthOnline Recreation

Outcome Measures

Primary Outcomes (4)

  • 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).

    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".

    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.

    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.

    Change from baseline health care utilization at 6 week

Secondary Outcomes (8)

  • Physical Activity Scale in the Elderly

    Change from baseline physical activity at 6 weeks

  • Social Engagement Survey

    Change from baseline social engagement at 6 weeks

  • Alternative Uses Task

    Change from baseline score at 6 weeks

  • Digit Span Test

    Change from baseline score at 6 weeks

  • Means-End Problem Solving

    Change from baseline score at 6 weeks

  • +3 more secondary outcomes

Study Arms (3)

ArtontheBrain

EXPERIMENTAL

ArtontheBrain application for about 30 to 45 minutes twice per week, over 6 weeks.

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.

Device: ArtontheBrainDevice: 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.

Device: ArtontheBrain

Interventions

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.

ArtontheBrainSeniors Online VictoriaWaitlist Control

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).

Seniors Online Victoria

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baycrest Health Sciences

Toronto, Ontario, M6A 2E1, Canada

Location

Related Publications (21)

  • 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.

    PMID: 24336875BACKGROUND
  • 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.

    PMID: 21479777BACKGROUND
  • 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.

    PMID: 19228398BACKGROUND
  • 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.

    PMID: 18042300BACKGROUND
  • 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.

    PMID: 8085500BACKGROUND
  • 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.

    PMID: 1593914BACKGROUND
  • 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.

    PMID: 26733272BACKGROUND
  • 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.

    PMID: 10391658BACKGROUND
  • 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.

    PMID: 8437031BACKGROUND
  • 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.

    PMID: 11970796BACKGROUND
  • 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.

    PMID: 12507363BACKGROUND
  • 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.

    PMID: 11296689BACKGROUND
  • 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.

    PMID: 15327726BACKGROUND
  • MEDNICK SA. The associative basis of the creative process. Psychol Rev. 1962 May;69:220-32. doi: 10.1037/h0048850. No abstract available.

    PMID: 14472013BACKGROUND
  • 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.

    PMID: 18675285BACKGROUND
  • Ritter PL, Stewart AL, Kaymaz H, Sobel DS, Block DA, Lorig KR. Self-reports of health care utilization compared to provider records. J Clin Epidemiol. 2001 Feb;54(2):136-41. doi: 10.1016/s0895-4356(00)00261-4.

    PMID: 11166528BACKGROUND
  • Beauchet O, Launay CP, Merjagnan C, Kabeshova A, Annweiler C. Quantified self and comprehensive geriatric assessment: older adults are able to evaluate their own health and functional status. PLoS One. 2014 Jun 26;9(6):e100636. doi: 10.1371/journal.pone.0100636. eCollection 2014.

    PMID: 24968016BACKGROUND
  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PMID: 15817019BACKGROUND
  • Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4.

    PMID: 7183759BACKGROUND
  • Boot WR, Charness N, Czaja SJ, Sharit J, Rogers WA, Fisk AD, Mitzner T, Lee CC, Nair S. Computer proficiency questionnaire: assessing low and high computer proficient seniors. Gerontologist. 2015 Jun;55(3):404-11. doi: 10.1093/geront/gnt117. Epub 2013 Oct 9.

    PMID: 24107443BACKGROUND
  • Fraser KD, O'Rourke HM, Wiens H, Lai J, Howell C, Brett-MacLean P. A Scoping Review of Research on the Arts, Aging, and Quality of Life. Gerontologist. 2015 Aug;55(4):719-29. doi: 10.1093/geront/gnv027.

    PMID: 26179707BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionDementia

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Kelly Murphy, Ph.D

    Baycrest Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

May 25, 2018

First Posted

June 11, 2018

Study Start

July 24, 2018

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

February 27, 2019

Record last verified: 2019-01

Locations