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Visualisation of a Digital Care Pathway.

7 de fevereiro de 2022 atualizado por: Jessa Hospital

Visualisation of a Digital Care Pathway in Limburg, in Context of Digital Care Support as a Stepping Stone for Flanders.

As part of the EFRO (Europees Fonds Regionale Ontwikkeling) 1302 project "Digital Care Support in Practice with Limburg as a Stepping Stone for Flanders", this study aims to evaluate the concept and added value of visualising a personal digital care pathway for patients with type 2 diabetes. Firstly, this chronological visualisation of data strives to improve patient experience and empowerment by offering educational articles and personal medical data relevant to their care path in one place. This way, patients will have more insight in the pathogenesis, treatments, complications and goals, allowing the patients to optimize their selfcare and become confident in dealing with their chronic condition. From time to time, patients will also be asked to complete questionnaires concerning their experiences (PREM) to aid healthcare professionals in personalizing treatment goals. Secondly, the healthcare providers and caregivers surrounding the patient will also have access to the same data, allowing for a more personal approach as well as means to communicate with other members of the care team.

Visão geral do estudo

Descrição detalhada

Good quality of care requires a multidisciplinary approach, especially with chronic illnesses. Therefore, all members of the care team should be adequately informed and communicate well with each other. Additionally, patients should have a key role in their treatment plan. To successfully optimize self care, patients have to be well-informed about pathogenesis, treatments and complications so that expectations are realistic and attainable goals can be set. Currently, access to this relevant data is fragmented and often unavailable.

The newly developed application creates a central platform where all relevant data, educational material, medication scheme... are available for both the patient and healthcare professionals. The targeted study population are patients with type 2 diabetes who will be recruited by their general practitioner (GP) over a period of 3 months. When patients are interested in partaking, they will be contacted by a healthcare professional who will function as a Single Point of Contact (SPOC) for the patient during the entirety of the study with a maximum duration of 6 months. The SPOC helps with the start up of the application, collects administrative data and contacts the participants at regular intervals to help with difficulties in using the application. Furthermore, the SPOC will administer a questionnaire determining patient involvement and experience at the start and end of the study, as well as conduct an in-depth interview when the study is completed. Throughout the study, other questionnaires will be digitally available for the patient as part of the care path. These patient reported outcome and experience measures (PROM/PREM) will support healthcare professionals in providing a more integral care.

Consequently, involved healthcare professionals will also be contacted, informed and asked to complete a questionnaire once healthcare professionals agree to participate in the study. This questionnaire will focus on the information and communication needs between members of the care team and will also be repeated at the end, followed by an in-depth interview.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

45

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.

Contato de estudo

Estude backup de contato

Locais de estudo

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 for cohort 1 and 2:

  • patients with type 2 diabetes (voortraject and zorgtraject)
  • independent and mentally competent
  • digitally literate and in possession of an email address
  • mastered the Dutch language
  • able to visit the GP (no house calls)

Additional inclusion criteria for cohort 2 :

  • presence of a home nurse in the context of the Diabetes care
  • presence of a home care service

Exclusion Criteria:

  • patients type 2 Diabetes enrolled in the Diabetes convention
  • pregnant patients
  • illiterate people
  • patients living in a residential care center

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: Não randomizado
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: patients

Implementation and visualisation of digital care path. Pre measurement: questionnaire quantifying patient involvement and experience on a 5-p Likert scale.

Post measurement: questionnaire quantifying patient involvement and experience on a 5-p Likert scale, questionnaire quantifying usability of the tool and in-depth interview.

The implementation and visualisation of a digital care path, specifically designed for patients with type 2 diabetes and their care team. The digital care path wil include: 1) a timeline with appointments, messages and questionnaires 2) Diabetes related articles 3) a page for monitoring clinical parameters and goals 4) a section displaying information on their care team and personal health records. The aim of this intervention is to evaluate whether providing a central platform for all data will increase patient empowerment and involvement. Secondly it will also evaluate whether the communication between healthcare professionals improves when selected data is readily available for the entire care team.
Experimental: healthcare professionals

Implementation and visualisation of digital care path. Pre measurement: questionnaire quantifying communication needs and experiences on a 5-p Likert scale.

Post measurement: questionnaire quantifying communication needs and experiences on a 5-p Likert scale, questionnaire quantifying usability of the tool and in-depth interview.

The implementation and visualisation of a digital care path, specifically designed for patients with type 2 diabetes and their care team. The digital care path wil include: 1) a timeline with appointments, messages and questionnaires 2) Diabetes related articles 3) a page for monitoring clinical parameters and goals 4) a section displaying information on their care team and personal health records. The aim of this intervention is to evaluate whether providing a central platform for all data will increase patient empowerment and involvement. Secondly it will also evaluate whether the communication between healthcare professionals improves when selected data is readily available for the entire care team.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in patient empowerment and involvement
Prazo: For a minimum of 12 weeks

Primary outcome measures will be determined with the aid of a questionnaire scoring answers on a 5p-Likert scale. Due to limited availability of validated questionnaires in Dutch, a custom set of questions was generated. Starting from validated English questionnaires on each topic, the Delphi method was used to reach consensus in selecting the final questions.

At the end of the study, an in-depth interview will take place with a predefined topic list.

For a minimum of 12 weeks
Change in care team communication and sharing of data
Prazo: For a minimum of 12 weeks

Primary outcome measures will be determined with the aid of a questionnaire scoring answers on a 5p-Likert scale. Due to limited availability of validated questionnaires in Dutch, a custom set of questions was generated. Starting from validated English questionnaires on each topic, the Delphi method was used to reach consensus in selecting the final questions.

At the end of the study, an in-depth interview will take place with a predefined topic list.

For a minimum of 12 weeks
Usability and acceptance of the application in patients and healthcare professionals
Prazo: For a minimum of 12 weeks

Primary outcome measures will be determined with the aid of a questionnaire scoring answers on a 5p-Likert scale. Due to limited availability of validated questionnaires in Dutch, a custom set of questions was generated. Starting from validated English questionnaires on each topic, the Delphi method was used to reach consensus in selecting the final questions.

At the end of the study, an in-depth interview will take place with a predefined topic list.

For a minimum of 12 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
User characteristics of the application.
Prazo: for a minimum of 12 weeks
Data will be collected from logs, available in the back office of the application
for a minimum of 12 weeks
Possible change,impact on personal clinical parameters: HbA1c
Prazo: for a minimum of 12 weeks
HbA1c will be expressed in %
for a minimum of 12 weeks
Possible change,impact on personal clinical parameters: blood pressure
Prazo: For a minimum of 12 weeks
Both systolic and diastolic blood pressure will be measured, expressed in mmHg.
For a minimum of 12 weeks
Possible change,impact on personal clinical parameters: glycemia
Prazo: For a minimum of 12 weeks
Glycemia will be expressed in mg/dl.
For a minimum of 12 weeks
Possible change,impact on personal clinical parameters: girth
Prazo: For a minimum of 12 weeks
Girth will be expressed in cm.
For a minimum of 12 weeks
Possible change,impact on personal clinical parameters: bodyweight
Prazo: For a minimum of 12 weeks
Weight will be expressed in kg.
For a minimum of 12 weeks

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Yves Breysem, Dr, Jessa Hospital

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)

1 de outubro de 2021

Conclusão Primária (Antecipado)

28 de fevereiro de 2022

Conclusão do estudo (Antecipado)

30 de junho de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

27 de outubro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de janeiro de 2022

Primeira postagem (Real)

7 de fevereiro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de fevereiro de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de fevereiro de 2022

Última verificação

1 de janeiro de 2022

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 2021/036

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

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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