NCT05766319

The ICU-recover Box, Using Smart Technology for Monitoring Health Status After ICU Admission

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Main study parameters/endpoints: The primary endpoint of the study will be 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.

Conditions

• Critically Ill
• ICU Survivor
• User Experience

Interventions

Type	Name	Description
DEVICE	Withings ScanWatch	Withings ScanWatch, from which the following features will be used: * Measurement of peripheral oxygen saturation (%) * Automatic recording of heart rate (beats/min) * Automatic recording of activity (step count) (numbers/day)
DEVICE	Withings BPM Connect	Withings BPM connect, from which the following feature will be used: o Measurement of non invasive bloodpressure (mmHg)
DEVICE	Withings Body	Withings Body (Scale), from which the following feature will be used: o Measurement of body weight (kg)

Timeline

• Start date: 2022-09-26
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2023-03-13
• Last updated: 2024-06-14

Locations

1 site across 1 country: Netherlands