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Evaluation of Patient Education Simulations to Promote Health and Wellness

7 de fevereiro de 2022 atualizado por: NYU Langone Health

Evaluation of Patient Education Simulations to Promote Health and Wellness in Patients With Chronic Disease

This pilot study will use a pre-post design to explore the utility of using virtual simulations to provide participant education and counseling for adopting healthy lifestyle behaviors (i.e., physical activity, nutrition, smoking, alcohol use, and anxiety/distress screening) to 60 participants with chronic diseases where lifestyle management is paramount to well-being and disease control (e.g., cardiovascular disease, stroke, diabetes, cancer, chronic obstructive pulmonary disease, osteoarthritis). Participants will have access to the simulations through a unique password-protected link over the course of one month. Participants will complete two study visits that are 30-60 minutes in duration each. There is also one optional telephone interview with a mental health professional. The telephone interview it estimated to be 10 minutes in duration and will be audiotapes, with participants' permission. The study surveys will be administrated at baseline, immediately following the simulation use and at one-month baseline measures. The measures will assess lifestyle behaviors related to healthy eating, physical activity, emotional health, smoking behaviors and alcohol use. Measures will also assess the psycho-social constructs of intrinsic motivation and self-efficacy. Finally, the usability of and satisfaction with the simulations will be explored through feedback surveys. The investigator will also seek permission to collect data from the patient's medical chart. Feedback will also be collected from four healthcare providers.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

The overarching goal of the pilot study is to assess the acceptability and potential efficacy of the participant education simulation on changes in participants with chronic diseases' lifestyle behaviors as well as motivation and self-efficacy to change.

The primary objective is to examine the acceptability (satisfaction, usability) of using virtual simulations to deliver participant education and counseling for adopting healthy lifestyle behaviors among a sample of four healthcare providers and 60 participants with chronic disease. The secondary objectives include examining changes in lifestyle behaviors (e.g., healthy eating, physical activity) one-month following the use of the participant education simulations in a sample of 60 participants with chronic disease (e.g. cancer, cardiovascular disease, diabetes, stroke, arthritis) and to explore the potential mediators (e.g. motivation and self-efficacy) of the simulation effects on the changes in participants' lifestyle behaviors.

Participants will communicate with a virtual human, Linda, by selecting from a dynamic menu of dialogue options. Once the learner chooses a dialogue option, they see the virtual human respond by providing personalized feedback and give users an opportunity to revise their choice. In this study, the simulations will be a bundle of four topic-based conversations with Linda, which include fitness and nutrition, smoking cessation, alcohol use, distress and anxiety.

Tipo de estudo

Intervencional

Inscrição (Real)

37

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

  • Estados Unidos
    • New York
      • New York, New York, Estados Unidos, 10016
        • NYU Langone Health

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

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

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Age 18 years or older;
  2. Have a diagnosis of a chronic disease (e.g., osteoarthritis, coronary artery disease, chronic obstructive pulmonary disease, asthma, diabetes, hypertension, stroke, and congestive heart failure) as indicated by self-report or review of the electronic medical record; and
  3. Receiving care within the NYU Langone Health Network (e.g., Faculty Group Practices and ambulatory care centers, NYU Winthrop Surgical Associates)

Exclusion Criteria:

  1. Are unable to give informed consent
  2. Refuse to participate
  3. Any active terminal illness, mental incompetence, or uncontrolled psychiatric illness. These exclusions were based on the premise that the presence of any of these conditions would dominate the subject's perception of lifestyle management of their chronic disease.
  4. Unable to speak and read in English. Patients that are unable to speak and read in English will be excluded from the proposed project because the simulations are being developed in English only. Once we demonstrate the initial efficacy of this tool, future simulations will be developed in languages other than English. Despite the language restrictions, no exclusion will be made based on patient racial/ethnic origin.

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: Outro
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Virtual Education Simulation
All participants will have access to the virtual education simulations.
Comportamental: Virtual Education Simulation

The simulations will be developed using Kognito's proprietary Conversation Platform.

In this pilot study, the simulations will be a bundle of four topic-based conversations with Linda, a virtual peer with a chronic disease. The four wellness topics are:

  1. Fitness & Nutrition
  2. Smoking Cessation
  3. Alcohol Use
  4. Distress & Anxiety

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of participants who were unsatisfied and satisfied by use of virtual simulations for education delivery and counseling
Prazo: Immediately post-simulation (Day 0)
A Usability Questionnaire will be used for participants to rate how much they agree or disagree with 14 questions as they relate to the participants' conversation with the virtual coach. Choices for each question range include: strongly disagree, somewhat disagree, somewhat agree, and strongly agree. No numerical scale is used.
Immediately post-simulation (Day 0)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in score of Alcohol Abstinence Self-Efficacy (AASE) Scale
Prazo: Baseline (Day 0), Day 30 +/- 7 days post-intervention
The AASE Scale consists of 40 situations that lead some people to drink. Participants mark answers which reflect how tempted they may be to drink in each situation at the present time. The answers choices range from 0 (not at all) to 4 (extremely). The range of score is 0-160. The higher the score, the higher the temptation to drink.
Baseline (Day 0), Day 30 +/- 7 days post-intervention
Score of Short Portable Mental Status Questionnaire (SPMSQ)
Prazo: Baseline (Day 0)
10 questions will be asked to the participants. All responses must be given without reference to calendar, newspaper, birth certificate, or other aid to memory. The total number of errors based on the answers to the 10 questions will be recorded as the score. The lower the score, the better. 0-2 errors = Intact Intellectual Functioning, 3-4 errors = Mild Intellectual Impairment, 5-7 errors = Moderate Intellectual Impairment, 8-10 errors = Severe Intellectual Impairment.
Baseline (Day 0)
Change in score of Smoking Abstinence Self-Efficacy Questionnaire (SASEQ)
Prazo: Baseline (Day 0), Day 30 +/- 7 days post-intervention
The SASEQ consists of 6 situations that lead some people to smoke. Participants mark answers which reflect how confident they feel that they will not smoke in each situation. The answer choices range from 0 (certainly) to 4 (certainly not). The range of score is 0-24.
Baseline (Day 0), Day 30 +/- 7 days post-intervention
Score of Patient Health Questionnaire-8 (PHQ-8)
Prazo: Baseline (Day 0)
PHQ-8 consists of 8 problem situations. The questionnaire asks the participants how often they have been bothered by each problem over the last 2 weeks. The total score ranges from 0-12, with categories of psychological distress being: none (0-2), mild (3-5), moderate (6-8), and severe (9-12). Therefore, the lower the score, the better.
Baseline (Day 0)
Change in amount of days of physical activity
Prazo: Baseline (Day 0), Day 30 +/- 7 days post-intervention
Three types of physical activity will be reported on: vigorous, moderate, and walking. Participants will report how many days they did vigorous physical activities (like heavy lifting, digging, aerobics, or fast bicycling), how many days they did moderate (carrying light loads, bicycling at a regular pace, doubles tennis), and how many days they walked for at least 10 minutes during the last 7 days.
Baseline (Day 0), Day 30 +/- 7 days post-intervention
Change in Score of Self Efficacy Fruits and Vegetables Questionnaire
Prazo: Baseline (Day 0), Day 30 +/- 7 days post-intervention
This questionnaire consists of 10 statements. The participant must rate how confident they are about each of the statements. The responses range from 0 (not at all sure) to 3 (very sure). The total score ranges from 0-30. The higher the score, the more confident the participant is about incorporating fruits and vegetables into their lifestyle.
Baseline (Day 0), Day 30 +/- 7 days post-intervention
Change in Score of Self Efficacy Exercising Questionnaire
Prazo: Baseline (Day 0), Day 30 +/- 7 days post-intervention
This questionnaire consists of 11 statements. The participant must rate how confident they are about each of the statements. The responses range from 0 (not at all sure) to 3 (very sure). The total score ranges from 0-30. The higher the score, the more confident the participant is about incorporating exercise into their lifestyle.
Baseline (Day 0), Day 30 +/- 7 days post-intervention
Change in Intrinsic Motivation for Eating Fruits and Vegetables
Prazo: Baseline (Day 0), Day 30 +/- 7 days post-intervention
In the format of a questionnaire, participants are asked to indicate the extent to which each reason is true for them, using a 7-point scale. Why they eat fruits and vegetables (from a list of 17 reasons). Each individual question is assessed separately, so no total range is given.
Baseline (Day 0), Day 30 +/- 7 days post-intervention
Change in Intrinsic Motivation for Exercising
Prazo: Baseline (Day 0), Day 30 +/- 7 days post-intervention
In the format of a questionnaire, participants are asked to indicate the extent to which each reason is true for them, using a 7-point scale. Why they choose to exercise (from a list of 15 reasons).
Baseline (Day 0), Day 30 +/- 7 days post-intervention
Self Efficacy in Seeking Mental Health Treatment (SESMHC)
Prazo: Immediately post-simulation (Day 0)
This questionnaire consists of 9 statements. Participants are asked to rate how confident they are about each of the statements. Their responses range from 0 (no confidence) to 4 (complete confidence). The total score ranges from 0-36. The higher the score, the more confident the participant is about seeking mental health care.
Immediately post-simulation (Day 0)

Colaboradores e Investigadores

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

Patrocinador

NYU Langone Health

Investigadores

  • Investigador principal: Antoinette Shoenthaler, EdD, NYU Langone Health

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)

5 de dezembro de 2019

Conclusão Primária (Real)

24 de julho de 2021

Conclusão do estudo (Real)

1 de outubro de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

16 de abril de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de abril de 2020

Primeira postagem (Real)

20 de abril de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de fevereiro de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de fevereiro de 2022

Última verificação

1 de fevereiro de 2022

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 19-00460

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Sim

Descrição do plano IPD

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.

Prazo de Compartilhamento de IPD

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

Critérios de acesso de compartilhamento IPD

The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Antoinette.Schoenthaler@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Tipo de informação de suporte de compartilhamento de IPD

  • Protocolo de estudo
  • Plano de Análise Estatística (SAP)

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

produto fabricado e exportado 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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