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

26 de fevereiro de 2019 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

110

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Ontario
      • Toronto, Ontario, Canadá, M6A 2E1
        • Baycrest Health Sciences

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

60 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: ArtontheBrain
ArtontheBrain application for about 30 to 45 minutes twice per week, over 6 weeks.
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.
Comparador Ativo: 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.
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).
Outro: Waitlist Control
The waitlist control group will no treatment for 6 weeks, after which they will six weeks of the ArtontheBrain intervention.
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
EQ-5D-5L
Prazo: 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).
Change from baseline quality of life at 6 week
Short Warwick-Edinburg Mental Well-Being Scale (WEMWBS)
Prazo: 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".
Change from baseline mental wellbeing at 6 weeks
Short-Form Health Survey (SF-36)
Prazo: 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.
Change from baseline SF-36 score at 6 week
Stanford Health Care Utilization
Prazo: 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.
Change from baseline health care utilization at 6 week

Medidas de resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Kelly Murphy, Ph.D, Baycrest Health Sciences

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

24 de julho de 2018

Conclusão Primária (Antecipado)

31 de março de 2019

Conclusão do estudo (Antecipado)

31 de março de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

25 de maio de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de junho de 2018

Primeira postagem (Real)

11 de junho de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de fevereiro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de fevereiro de 2019

Última verificação

1 de janeiro de 2019

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • #17-49

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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