ICU-Recover Box 2.0, Smart Technology for Home Monitoring of ICU Patients

NCT07162948 | Recruiting

• 1 other identifier: NL86464.058.24
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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. With the ICU-Recover Box and its smart technology the investigators see new opportunities to improve patient health and to recognize early if escalation of medical care is needed. The primary objective of the pilot study is to assess the feasibility of the use of smart technology by persons that have been discharged from the ICU in the twelve months following ICU discharge.

Conditions

ICU Acquired Weakness

Keywords

smart technology; post-ICU recovery; post intensive care syndrome; health care utilization; health related quality of life

Outcome Measures

Primary Outcomes (2)

• Use of smart technology

  · The percentage of included post-ICU patients that was able to use and actually did use smart technology for twelve consecutive months.

  12 months

• Acquisition of data

  · That it was possible (y/n) to acquire the data from the remote monitoring and that the investigators were able to store and use the data for analyses

  12 months

Secondary Outcomes (1)

• Lessons Learnt

  12 months

Study Arms (1)

Patients receiving the ICU-recover box containing home monitoring devices

OTHER

Treatment of subjects on the ICU and on the ward will be 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 the Corsano CardioWatch 287-2 and a Corsano blood pressure cuff after they have given informed consent. Descriptions of the Corsano CardioWatch 287-2 and the blood pressure cuff are given in further detail in section 6 of this protocol. Patients will also be asked to answer three short questionnaires regularly via telephone namely the ICU-CONTENT short (37 items), health care utilization questionnaire and the user friendliness questionnaire.

Device: The ICU-Recover Box: using smart technology for monitoring health status after ICU admission Pilot 2.0

Interventions

The ICU-Recover Box: using smart technology for monitoring health status after ICU admission Pilot 2.0 DEVICE

The Corsano CardioWatch 287-2 measures blood pressure, heart rate, heart rate variability, respiratory rate, peripheral oxygen saturation, body temperature and their daily activity.This devices is used for personal management, never to directly base a diagnosis or treatment on. The patient has to download the Corsano App on his/her mobile phone.

Patients receiving the ICU-recover box containing home monitoring devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has been admitted to the ICU of the LUMC for \> 24 hours.
• Patient has received mechanical ventilation.
• Patient masters the English or Dutch language.
• Patient is able 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 or an extra-hospital facility.

You may not qualify if:

• Patient is \< 18 years old.
• Patient is pregnant.
• Patient breastfeeds during the course of the 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

MeSH Terms

Conditions

postintensive care syndrome; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Sesmu Arbous, MD PhD

CONTACT

+31715265018; marbous@lumc.nl

Tina van Hemel-Rintjap, MD

CONTACT

+31715265018; J.D.van_Hemel@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor dr MS Arbous, anesthesiologist-intensivist

Model Details: The primary objective of this pilot study is to assess the feasibility of the use of smart technology, i.e. Corsano CardioWatch 287-2 and blood pressure monitor assembled in the so-called ICU-Recover Box, by persons that have been discharged from the ICU in the one year following hospital discharge.

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: September 9, 2025
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

NL (1)