SHIFT-Hospital in Motion: Use of Activity Sensors in the Clinical Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Evaluation of the time expenditure
研究概览
简要总结
The goal of this monocentric observational study involving hospitalised patients is to assess the integration of activity sensors into routine clinical practice.
详细描述
Patients in hospitals spend the majority of their time inactive, sitting or lying down. Not being active is a common problem for patients in hospitals, often causing complications and impairing recovery, as it can lead to issues such as reduced blood volume, unsteady blood pressure when standing, weaker muscles, and a higher risk of infections, blood clots, and other health issues. The inactivity-related changes in the body in combination with the natural ageing process, the stress of being in the hospital, a poor nutritional status, and possibly troubles with thinking, memory, and understanding or depression diminish the ability to regenerate with overall compromised physiological resilience.
A pilot study (NCT06403826) involving 40 patients demonstrated the feasibility and effectiveness of using activity sensors in clinical settings. A subsequent validation study (NCT06396676) validated a classification model based on activity data from 65 patients, which can distinguish between different activities with 89% accuracy.
The integration of activity sensors into routine clinical practice requires a comprehensive infrastructure to support interdisciplinary collaboration. Therefore, the primary objective of this observational, single center study is to evaluate the additional time expenditure associated with using activity sensors in routine clinical practice by physiotherapy and clinical care over a 10-week period. Secondary objectives include assessing the comfort of extended sensor use, the feasibility and benefits for healthcare professionals, the reliability and accuracy of the sensor data, and the optimization of the activity classification algorithm.
The results of this study will contribute to improving patient care through the use of activity sensors, enabling more personalized care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 3 days inpatient on the medical ward 6.1 (Monday to a maximum of Thursday or Tuesday to a maximum of Friday)
- •at least restricted bed rest
- •patient must be able to walk
- •patient must be cognitively able to follow instructions (normal Observation Screening Scale (DOS) und modified Confusion Assessment Method (mCAM))
- •≥ 18 years
- •signed informed consent
排除标准
- •planned discharge within the next 3 days
- •planned surgery during the measurement
- •isolated patient
- •inability or contraindications to participate in the study or to follow the study procedures, e.g. due to certain neurological disorders, speech problems, mental disorders, or cognitive impairments
- •prior inclusion in the study
结局指标
主要结局
Evaluation of the time expenditure
时间窗: Day 1-4
Using a study-specific questionnaire, the additional time expenditure associated with the use of activity sensors by physiotherapy and clinical care is evaluated.
次要结局
- Assessment of the comfort level associated with wearing the sensors(Day 2-4)
- Evaluation of the handling(After 10-week period (at recruitment completion))
- Assessment of the accuracy of the classification algorithm for the detection of movements parameters(Day 1-3)
- Optimization of activity classification algorithm(After 10-week period (at recruitment completion))