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Clinical Trials/NCT03551483
NCT03551483UnknownNot Applicable

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

Baycrest2 sites in 1 country110 target enrollmentStarted: July 24, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
110
Locations
2
Primary Endpoint
Short-Form Health Survey (SF-36)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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;
  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

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".

Secondary Outcomes

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

Investigators

Sponsor
Baycrest
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kelly Murphy, Ph.D., C.Psych

Psychologist

Baycrest

Study Sites (2)

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