ArtontheBrain: An Inclusive Evidence-based Cognitive Health App for Older Adults to Promote Aging at Home
2019年2月26日 更新者：Kelly Murphy, Ph.D., C.Psych、Baycrest
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.
調査の概要
状態
わからない
詳細な説明
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.
研究の種類
介入
入学 (予想される)
110
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ontario
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Toronto、Ontario、カナダ、M6A 2E1
- Baycrest Health Sciences
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
60年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：ArtontheBrain
ArtontheBrain application for about 30 to 45 minutes twice per week, over 6 weeks.
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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.
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アクティブコンパレータ：Seniors Online Victoria
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.
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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.
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).
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他の：Waitlist Control
The waitlist control group will no treatment for 6 weeks, after which they will six weeks of the ArtontheBrain intervention.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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EQ-5D-5L
時間枠：Change from baseline quality of life at 6 week
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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).
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Change from baseline quality of life at 6 week
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Short Warwick-Edinburg Mental Well-Being Scale (WEMWBS)
時間枠：Change from baseline mental wellbeing at 6 weeks
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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".
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Change from baseline mental wellbeing at 6 weeks
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Short-Form Health Survey (SF-36)
時間枠：Change from baseline SF-36 score at 6 week
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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.
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Change from baseline SF-36 score at 6 week
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Stanford Health Care Utilization
時間枠：Change from baseline health care utilization at 6 week
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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.
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Change from baseline health care utilization at 6 week
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Physical Activity Scale in the Elderly
時間枠：Change from baseline physical activity at 6 weeks
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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.
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Change from baseline physical activity at 6 weeks
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Social Engagement Survey
時間枠：Change from baseline social engagement at 6 weeks
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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.
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Change from baseline social engagement at 6 weeks
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Alternative Uses Task
時間枠：Change from baseline score at 6 weeks
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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
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Change from baseline score at 6 weeks
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Digit Span Test
時間枠：Change from baseline score at 6 weeks
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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.
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Change from baseline score at 6 weeks
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Means-End Problem Solving
時間枠：Change from baseline score at 6 weeks
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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.
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Change from baseline score at 6 weeks
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Art Engagement Survey
時間枠：Change in baseline score at 6 weeks
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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.
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Change in baseline score at 6 weeks
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Life Space Questionnaire (LSQ)
時間枠：Change in baseline score at 6 weeks
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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.
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Change in baseline score at 6 weeks
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Autobiographical Interview
時間枠：Change in baseline score at 6 weeks
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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
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Change in baseline score at 6 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Kelly Murphy, Ph.D、Baycrest Health Sciences
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年7月24日
一次修了 (予想される)
2019年3月31日
研究の完了 (予想される)
2019年3月31日
試験登録日
最初に提出
2018年5月25日
QC基準を満たした最初の提出物
2018年6月7日
最初の投稿 (実際)
2018年6月11日
学習記録の更新
投稿された最後の更新 (実際)
2019年2月27日
QC基準を満たした最後の更新が送信されました
2019年2月26日
最終確認日
2019年1月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- #17-49
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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