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

Leiden University Medical Center (LUMC)

Status: Enrolling

Conditions: ICU Acquired Weakness

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07162948

NL86464.058.24

Details and patient eligibility

About

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.

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 one has to adopt new ways of acquiring patient-specific knowledge and new ways of delivering care. To obtain this level of insight one needs a smart and connected health care system. 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. By intervening early, one can possibly improve the quality of life for a patient and reduce costs by reducing health care utilization.

Objectives: 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. If this pilot study proves to be successful, smart technology will be used in future studies.

Study design: This is a single centre cohort study. Study population: The study population consists of 50 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 on the general ward closely before hospital discharge. The ICU-Recover Box will contain the Corsano CardioWatch 287-2. This is a Conformité Européenne (CE)-marked wristwatch-sized medical device, designed to monitor a comprehensive array of vital parameters, blood pressure, heart rate, heart rate variability, respiratory rate, peripheral oxygen saturation, body temperature and their daily activity.. Results of any of the measurements will never be used for therapy or diagnosis. To calibrate the blood pressure function of the Corsano CardioWatch 287-2, the ICU-Recover Box will contain a blood pressure monitor. Furthermore, patients who take part in this study will be contacted at regular moments by phone (at 1, 2,3, 6, 9, and 12 months) for follow-up on quality of life, health care use, and satisfaction with the home monitoring device.

Main study parameters/endpoints: The primary endpoint of the study will be the feasibility of providing and following ICU patients with smart technology for twelve months after discharge from ICU of the Leiden University Medical Centre.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The Corsano CardioWatch 287-2 is Conformité Européenne (CE)-marked for medical use, non-invasive, easy-to-use and electrically safe within its intended use. Using this device is with very limited risks.

This study has some potential benefits for patients: first, patients can measure their own blood pressure, heart rate, heart rate variability, respiratory rate, peripheral oxygen saturation, body temperature and their daily activity. This can reassure patients and give them more insight in their own health (the so-called 'patient empowerment'). Furthermore, this data gives the doctor more insight in the health of patients. This might lead to early detection of infection, respiratory or circulatory insufficiency, and cognitive or mental impairment, but diagnoses are not directly based on measurements of the personal management devices. Patients will have their own responsibility for taking action in case of self-experienced deterioration.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Patients receiving the ICU-recover box containing home monitoring devices

Other group

Description:

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.

Treatment:

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