Clinical trial NCT05766319: The ICU-recover Box, Using Smart Technology for Monitoring Health Status After ICU Admission
Official title: The ICU-recover Box, Using Smart Technology for Monitoring Health Status After ICU Admission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill
ICU Survivor
User Experience
Keywords: E-health
Home monitoring devices
Smartphone-enabled
Health monitoring devices
Smart devices
User experience
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 10 patients who have been admitted to the ICU, at the Leiden University Medical Centre, and have been discharged to home will be using home monitoring for 3 consecutive months after hospital discharge
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of using home monitoring devices in terms of patient number
timeFrame: three months
measure: Feasibility of using home monitoring devices in terms of data acquisition
timeFrame: three months
measure: Feasibility of using home monitoring devices in terms of data storage
timeFrame: three months
measure: Feasibility of using home monitoring devices in terms of data analyzability
timeFrame: three to six months
measure: Feasibility of using home monitoring devices
timeFrame: six months
Secondary outcomes:
measure: Acceptability of home monitoring
timeFrame: three months
measure: Improvements of home monitoring
timeFrame: three months
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
affiliation: LUMC
name: Sesmu Arbous, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: