Clinical trial NCT03551483: ArtontheBrain: An Inclusive Evidence-based Cognitive Health App for Older Adults to Promote Aging at Home
Official title: ArtontheBrain: An Inclusive Evidence-based Cognitive Health App for Older Adults to Promote Aging at Home
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Impairment
Mild Cognitive Impairment
Dementia
Age-related Cognitive Decline
Aging
Keywords: Arts-based Intervention
Mobile Health
Online Recreation
Lead sponsor: Baycrest
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: Sheridan College
First posted: 2018-06-11
Enrollment: 110
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. 60 years of age and older.
2. Having normal or corrected to normal vision.
3. Self-reported proficiency in English.
4. Compliance with treatment, over the specified period of 6-weeks.
5. Having experienced:

   1. 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;
   2. 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.
   3. Early dementia as defined as MoCA score ≤23 with significant functional impairment in more than one iADLs domain.
6. Having access to a computer (e.g., desktop, laptop, tablet) and internet.

Exclusion Criteria:

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

Primary outcomes:
measure: EQ-5D-5L
timeFrame: Change from baseline quality of life at 6 week
measure: Short Warwick-Edinburg Mental Well-Being Scale (WEMWBS)
timeFrame: Change from baseline mental wellbeing at 6 weeks
measure: Short-Form Health Survey (SF-36)
timeFrame: Change from baseline SF-36 score at 6 week
measure: Stanford Health Care Utilization
timeFrame: Change from baseline health care utilization at 6 week
Secondary outcomes:
measure: Physical Activity Scale in the Elderly
timeFrame: Change from baseline physical activity at 6 weeks
measure: Social Engagement Survey
timeFrame: Change from baseline social engagement at 6 weeks
measure: Alternative Uses Task
timeFrame: Change from baseline score at 6 weeks
measure: Digit Span Test
timeFrame: Change from baseline score at 6 weeks
measure: Means-End Problem Solving
timeFrame: Change from baseline score at 6 weeks
measure: Art Engagement Survey
timeFrame: Change in baseline score at 6 weeks
measure: Life Space Questionnaire (LSQ)
timeFrame: Change in baseline score at 6 weeks
measure: Autobiographical Interview
timeFrame: Change in baseline score at 6 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Baycrest Health Sciences
state: Ontario
Study officials:
affiliation: Baycrest Health Sciences
name: Kelly Murphy, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: MEDNICK SA. The associative basis of the creative process. Psychol Rev. 1962 May;69:220-32. doi: 10.1037/h0048850. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.