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Visualisation of a Digital Care Pathway.

2022年2月7日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (预期的)

45

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:非随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
实验性的: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in patient empowerment and involvement
大体时间: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
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
User characteristics of the application.
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间:For a minimum of 12 weeks
Weight will be expressed in kg.
For a minimum of 12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Yves Breysem, Dr、Jessa Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年10月1日

初级完成 (预期的)

2022年2月28日

研究完成 (预期的)

2022年6月30日

研究注册日期

首次提交

2021年10月27日

首先提交符合 QC 标准的

2022年1月25日

首次发布 (实际的)

2022年2月7日

研究记录更新

最后更新发布 (实际的)

2022年2月24日

上次提交的符合 QC 标准的更新

2022年2月7日

最后验证

2022年1月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

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研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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