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

Leiden University Medical Center (LUMC)

Status: Completed

Conditions: ICU Survivor; Critically Ill; User Experience

Treatments: Device: Withings Body; Device: Withings ScanWatch; Device: Withings BPM Connect

Study type: Interventional

Funder types: Other

Identifiers

NCT05766319

NL81044.058.22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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..

Exclusion criteria

• 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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Patients receiving the ICU-recover box containing home monitoring devices

Experimental group

Description:

Treatment of subjects on the ICU will be state of the art, conform current practice, protocols and guidelines. Patients discharged from the ICU will receive an ICU-Recover Box on one of the clinical wards of the LUMC filled with several devices after they have given informed consent. These devices are listed below and are described in further detail in section 6 of this protocol. The ICU-Recover Box contains the following devices and tools: * Withings BPM Connect * Withings Body weight scale * Withings ScanWatch, from which the following features will be used: * Measurement of SpO2 * Automatic recording of heart rate * Automatic recording of activity (step count)

Treatment:

Device: Withings BPM Connect

Device: Withings ScanWatch

Device: Withings Body