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A Personalized Dashboard to Educate Veterans at Risk of Stroke

28 de outubro de 2015 atualizado por: VA Office of Research and Development

Personalized risk communication methods have been used to educate patients that are at a high risk of developing cardiovascular disease. These methods include personalized counseling, printed brochures and individualized graphs describing the status of the risk factors. Very few studies have provided an interactive tool for patients to self-manage their risk factors and observe the changes in risk by making lifestyle changes and modifying other risk factors by seeking medical advice.

This Rapid Response Project (RRP) builds upon these methods of communication by presenting the modifiable risk factors in the form of a personalized dashboard that highlights the contribution of these risk factors on the risk of developing a cardiovascular event. The modifiable risk factors that will be addressed in this study will include medical and lifestyle risk factors. The medical risk factors are hypertension, atrial fibrillation, diabetes mellitus and hyperlipidemia whereas the lifestyle risk factor is tobacco use.

Our primary goal is to develop a prototype of the dashboard to educate patients and help them make informed decisions in modifying their risk factors to reduce the probability of a cardiovascular event or stroke. We will also evaluate the effectiveness of this tool by asking these patients to return after 6 months to determine if they have made any lifestyle changes or pursued medical intervention to reduce their cardiovascular risk. We will make qualitative observations on the knowledge retention of these patients while using the interactive dashboard.

Visão geral do estudo

Descrição detalhada

Background:

Personalized risk communication methods have been used to educate patients who are at high risk of developing a cardiovascular event. These methods include personalized counseling, printed brochures and individualized graphs describing the status of the risk factors. Very few studies have provided an interactive tool for patients to use to compare the relative change in risk that might result from modifying their risk factors.

Objectives:

The goals of this pilot study were to: (a) develop a prototype of a personalized dynamic dashboard to educate veterans and help them make informed decisions about modifying their vascular risk factors (hypertension, diabetes mellitus, hyperlipidemia, and tobacco use) to reduce the probability of a vascular event; (b) test the usability of this tool from the patient's perspective; and (c) provide preliminary data regarding the effectiveness of this tool in terms of changes in lifestyle or risk factor control compared with nurse-education.

Methods:

This was a three-arm randomized controlled study. Veterans from the panel of one experienced general internist were randomly assigned to one of three groups: (1) dashboard with nurse-education, (2) nurse-education alone, (3) usual care. To be eligible, patients must have had at least two of the following: body mass index >30 kg/m2; current tobacco use; systolic blood pressure >140 mm Hg or diastolic >90 mm Hg; LDL-cholesterol >130 mg/dL, or hemoglobin Hb1Ac >8%. We developed the dashboard in our Human Computer Interface/Information Technology laboratory. Patients in the dashboard group received two in-person counseling sessions regarding methods for controlling risk factors, and were asked to use the dashboard tool to enter values for their own risk factors and to observe the relative effects of varying their risk factor control on their overall vascular risk. The nurse-education consisted of two in-person counseling sessions regarding methods for controlling risk factors. Both intervention sessions lasted approximately 30 minutes; therefore, the majority of the time was used to interact with the tool in the dashboard group whereas the entire time was used for personalized risk factor discussion in the nurse-education group. For the usual care group, data were retrospectively collected about the primary care visits and laboratory tests which took place during the same period as the visits for intervention patients.

Status:

Completed.

Tipo de estudo

Intervencional

Inscrição (Real)

77

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

    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202-2884
        • Richard Roudebush VA Medical Center, Indianapolis

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

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Veterans receiving care from a Primary Care Clinic at the Roudebush VA Medical Center in Indianapolis with at least two of the following risk factors:
  • Body Mass Index > 30
  • Current Smoker
  • Systolic Blood Pressure > 140 mm OR Diastolic Blood Pressure >90 mm
  • Cholesterol LDL > 130 mg/dL
  • Hemoglobin Hb1Ac > 8%

Exclusion Criteria:

  • Subjects on Dialysis
  • Subjects on Supplemental Oxygen

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: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição fatorial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Dashboard Plus Nurse
Patients randomized to this intervention arm were seen twice over six months by a research nurse to collect data on risk factors and received counseling plus a computerized dashboard intervention.
Patients received two in-person counseling sessions by a research nurse, approximately 3-7 months apart, in methods for controlling cardiovascular risk factors.
Patients receive two in-person counseling sessions, six months apart, in methods for controlling cardiovascular risk factors and were asked to use a computerized dashboard to enter values for the risk factors and observe the effects of the risk factors on the overall cardiovascular risk.
Experimental: Nurse Alone
Patients randomized to this intervention arm were seen twice over six months by a research nurse to collect data on risk factors and received counseling.
Patients received two in-person counseling sessions by a research nurse, approximately 3-7 months apart, in methods for controlling cardiovascular risk factors.
Sem intervenção: Control
Patients randomized to this group were followed retrospectively to collect data on their primary care visits and laboratory results and past medical history over the 12 month study period. They had no contact with study personnel and did not receive any type of intervention.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Percentage of Participants Who Initiate Conversation With Primary Care Provider About Vascular Risk
Prazo: From baseline to six-months
Only the intervention patients were analyzed for this outcome.
From baseline to six-months

Medidas de resultados secundários

Medida de resultado
Prazo
Change in Systolic Blood Pressure
Prazo: From baseline to six months
From baseline to six months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Mahesh Merchant, PhD MSc, Richard Roudebush VA Medical Center, Indianapolis

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

1 de julho de 2010

Conclusão Primária (Real)

1 de julho de 2011

Conclusão do estudo (Real)

1 de julho de 2011

Datas de inscrição no estudo

Enviado pela primeira vez

26 de maio de 2010

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de maio de 2010

Primeira postagem (Estimativa)

28 de maio de 2010

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

30 de outubro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de outubro de 2015

Última verificação

1 de outubro de 2015

Mais Informações

Termos relacionados a este estudo

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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