The ICU-recover Box, Using Smart Technology for Monitoring Health Status After ICU Admission
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Feasibility of using home monitoring devices in terms of data analyzability
研究概览
简要总结
In this pilot study we will study the feasibility of providing and following ICU patients with smart technology for three months after discharge from a general ward of the Leiden University Medical Centre.
详细描述
Rationale: Smart technology could improve quality of care in patients who have been admitted to the ICU and have been discharged from ICU and hospital, by early diagnosis of complications and early (ambulatory) treatment.
In times of increasing medical care consumption leading to increasing health care costs the investigators have to adopt new ways of acquiring patient-specific knowledge and new ways of delivering care. To obtain this level of insight the investigators need a smart and connected health care system. With the ICU-Recover Box and its smart technology we see new opportunities to improve patient health and to recognise early if escalation of medical care is needed. By intervening early the investigators can reduce costs by reducing health care utilization.
Objectives: The primary objective of the pilot study is to assess the feasibility of the introduction and use of smart technology by persons that have been discharged from the ICU in the three months following hospital discharge. If this pilot study proves to be successful, smart technology will be used in future studies.
Study design: This is a single center cohort study. Study population: The study population consists of 15 patients who have been discharged from the ICU Department to a general ward of the Leiden University Medical Centre.
Intervention: Patients who consent to take part in the study, receive an ICU-Recover Box closely before hospital discharge on the general ward. The ICU-Recover Box will contain a smartphone compatible blood pressure monitor, weight scale, and a watch containing a peripheral oxygen saturation monitor, a pedometer to monitor activity for home monitoring. Never will results of any of the measurements be used for therapy or diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 否
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •Patient has been admitted to the ICU of the LUMC for > 48 hours.
- •Patient has received mechanical ventilation for > 24 hours.
- •Patient masters the English or Dutch language.
- •Patient is able and capable to use smart technology at home. (i.e. Wi-Fi available, sufficient comprehension of smart technology).
- •Patient can be contacted and informed about the ICU-Recover box on one of the clinical wards of the LUMC.
- •Patient is discharged from a ward within the LUMC to home..
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Patient is < 18 years old.
- •Patient is pregnant.
- •Patient breastfeeds during the course of the study
- •Patient underwent cardiothoracic surgery (as they will receive the Cardiothoracic Box in another study).
- •Patient is discharged for palliative care.
- •Patient is considered an incapacitated adult.
- •Patient is unwilling to sign the informed consent form.
- •Patient is discharged to another hospital.
结局指标
主要结局
Feasibility of using home monitoring devices in terms of data analyzability
时间窗: three to six months
· We were able to analyse the acquired data (using Python).
Feasibility of using home monitoring devices
时间窗: six months
· · \> 80 % of the persons that were discharged with an ICU-Recover Box contributed for three months to post-ICU data
Feasibility of using home monitoring devices in terms of patient number
时间窗: three months
Primary endpoint of this study is the feasibility of providing patients with the ICU-Recover Box after ICU discharge and before hospital discharge, including the collection of measurement/questionnaire data after hospital discharge. This study will be used to identify the issues when implementing such a system. Feasibility is defined as: 10 post-ICU patients, who gave informed consent and who were discharged from hospital with the ICU-Recover Box, were able to use the devices within its intended use.
Feasibility of using home monitoring devices in terms of data storage
时间窗: three months
· We were able to store the acquired data in a safe manner in the datasafe of the LUMC
Feasibility of using home monitoring devices in terms of data acquisition
时间窗: three months
We were able to acquire data from the devices in the ICU-Recover Box. * Heart rate ( beats/min ) from the Withings ScanWartch * steps/day from the Withings ScanWatch * peripheral oxygen saturation (%) from the Withings ScanWatch * weight ( kg) from Withings Body * Blood pressure ( mmHg) from Withings BPM Connect
次要结局
- Improvements of home monitoring(three months)
- Acceptability of home monitoring(three months)
研究者
Sesmu M. Arbous, MD PhD MSc
dr.
Leiden University Medical Center