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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03551483
• Other study ID #: #17-49
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 24, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: January 2019
• Source: Baycrest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-related Cognitive Decline
• Aging
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Mild Cognitive Impairment

Intervention

Device:
• ArtontheBrain
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 Victoria
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).

Locations

Country	Name	City	State
Canada	Baycrest Health Sciences	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Baycrest	Sheridan College, University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (21)

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	Change from baseline physical activity at 6 weeks
Secondary	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.	Change from baseline social engagement at 6 weeks
Secondary	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	Change from baseline score at 6 weeks
Secondary	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.	Change from baseline score at 6 weeks
Secondary	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.	Change from baseline score at 6 weeks
Secondary	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.	Change in baseline score at 6 weeks
Secondary	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.	Change in baseline score at 6 weeks
Secondary	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	Change in baseline score at 6 weeks

External Links

•   ArtontheBrain Webpage