Wireless Assessment of Respiratory and Circulatory Distress - Europe
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,240
- 试验地点
- 5
- 主要终点
- Evaluation of monitoring practices and WARD-CSS feasibility
研究概览
简要总结
Hospital patient monitoring in Europe is often intermittent, which can delay detection of clinical deterioration during hospitalization and after discharge. The WARD-EU study aims to describe current monitoring practices and to evaluate the feasibility, acceptability, and usability of the WARD-CSS (Wireless Assessment of Respiratory and Circulatory Distress - Clinical Support System), an algorithm-based continuous monitoring system. The study seeks to assess whether WARD-CSS can be integrated into routine hospital and post-discharge care to support earlier detection of patient deterioration and improved patient monitoring.
详细描述
The WARD-EU study is a multinational, multicentric, mixed-methods observational investigation conducted across four European countries. The study is designed to explore variation in hospital patient monitoring practices and to evaluate the implementation potential of an algorithm-based continuous monitoring system across different healthcare settings.
The study consists of two sequential phases. Phase 1 (pre-implementation) focuses on mapping existing monitoring practices for adult patients admitted for medical or surgical conditions with an expected hospital stay of at least two days. Data will be collected using structured questionnaires administered to patients and nursing staff to characterize monitoring frequency, workflows, perceived safety, and user experience within participating healthcare systems.
Phase 2 (post-implementation) evaluates the integration of the WARD-CSS (Wireless Assessment of Respiratory and Circulatory Distress - Clinical Support System) into routine clinical practice. WARD-CSS combines wearable wireless sensors for continuous vital sign monitoring with an application incorporating clinically modelled algorithms designed to detect early signs of respiratory and circulatory deterioration while reducing unnecessary alerts. During this phase, the system will be used for in-hospital monitoring and, where feasible, extended to post-discharge home monitoring.
Data collection in Phase 2 will include questionnaires from healthcare professionals and patients to assess usability, feasibility, and acceptability of the system, as well as descriptive analysis of system-generated vital sign data, monitoring adherence, and measurement frequency. Complications occurring within 30 days following hospital discharge will be recorded. Qualitative feedback will be used to identify facilitators and barriers to implementation, including technological challenges, workflow integration, and patient compliance, particularly in home-monitoring settings.
The study will enroll adult patients and healthcare professionals from participating centers. Participants may be involved during hospitalization and, for selected patients, during home monitoring following discharge, with follow-up up to 30 days. Data will be analyzed descriptively using appropriate parametric and non-parametric methods to identify patterns and variability across countries and care settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (≥18 years) admitted to hospitals due to medical or surgical conditions with an expected hospital stay of at least two days.
- •Adults discharged from the hospital who are receiving home-based monitoring using WARD-CSS (Phase 2 only).
- •Willingness to participate and provide informed consent.
排除标准
- •Patients with severe comorbidities (e.g., severe dementia) that preclude continuous monitoring.
- •Patients unwilling or unable to provide informed consent.
- •Patients unable to wear the monitoring equipment.
研究组 & 干预措施
WARD-CSS Continuous Monitoring
Participants receive continuous monitoring using the WARD-CSS system during hospitalization and, where applicable, at home after discharge. Pre-implementation baseline data will be collected prior to WARD-CSS rollout for within-subject comparisons of usability, workflow integration, patient experience, adherence, and alert response.
干预措施: WARD-CSS (Wireless Assessment of Respiratory and Circulatory Distress - Clinical Support System) (Device)
结局指标
主要结局
Evaluation of monitoring practices and WARD-CSS feasibility
时间窗: From enrollment to up to seven days from either admission in the in-hospital cohort or discharge to home in the home monitoring cohort.
Implementation of the WARD-CSS continuous monitoring system will be evaluated using structured surveys administered to healthcare professionals and patients. Surveys include: Self-developed questionnaires for patients and healthcare professionals administered before and after implementation to assess perceived system performance, usability, workflow integration, and implementation challenges. mHealth App Usability Questionnaire (MAUQ) administered after implementation to assess usability (total and subscale scores calculated according to scoring guidelines; higher scores indicate better usability). Normalization Measure Development Questionnaire (NoMAD) administered after implementation to assess implementation integration into routine practice (total score calculated according to scoring guidelines; higher scores indicate greater normalization/integration). For each instrument, mean total scores will be reported based on their respective validated scoring systems.
次要结局
- Patient experience and usability(From enrollment to up to seven days from either admission in the in-hospital cohort or discharge to home in the home monitoring cohort.)
研究者
Eske Kvanner Aasvang
Prof
Rigshospitalet, Denmark