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

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.

Study Overview

• Status: Recruiting
• Conditions: Critically Ill; ICU Survivor; User Experience
• Intervention / Treatment: Device: Withings ScanWatch; Device: Withings BPM Connect; Device: Withings Body

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sesmu Arbous, MD PhD MSc; Phone Number: +31 0626488225; Email: marbous@lumc.nl
• Study Contact Backup: Name: Tina van Hemel-Rintja[, MD; Phone Number: +31 0624148712; Email: J.D.van_Hemel-Rintjap@lumc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2333 ZA
      • Recruiting
      • Leiden University Medical Center
      • Contact: Sesmu Arbous, MD PhD; Phone Number: 0626488225; Email: marbous@lumc.nl
      • Contact: Tina van Hemel-Rintjap, MD; Phone Number: +31 0624148712; Email: J.D.van_Hemel-Rintjap@lumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients receiving the ICU-recover box containing home monitoring devices; 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 SpO2Automatic recording of heart rateAutomatic recording of activity (step count)

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of using home monitoring devices in terms of patient number	Primary endpoint of this study is the feasibility of providing patients with the ICU-Recover Box after ICU discharge and before hospital discharge, including the collection of measurement/questionnaire data after hospital discharge. This study will be used to identify the issues when implementing such a system. Feasibility is defined as: 10 post-ICU patients, who gave informed consent and who were discharged from hospital with the ICU-Recover Box, were able to use the devices within its intended use.	three months
Feasibility of using home monitoring devices in terms of data acquisition	We were able to acquire data from the devices in the ICU-Recover Box.; Heart rate ( beats/min ) from the Withings ScanWartch; steps/day from the Withings ScanWatch; peripheral oxygen saturation (%) from the Withings ScanWatch; weight ( kg) from Withings Body; Blood pressure ( mmHg) from Withings BPM Connect	three months
Feasibility of using home monitoring devices in terms of data storage	· We were able to store the acquired data in a safe manner in the datasafe of the LUMC	three months
Feasibility of using home monitoring devices in terms of data analyzability	· We were able to analyse the acquired data (using Python).	three to six months
Feasibility of using home monitoring devices	· · > 80 % of the persons that were discharged with an ICU-Recover Box contributed for three months to post-ICU data	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of home monitoring	Secondary endpoints are: · Users, i.e. post-ICU patients, have been asked, by short interviews, for feedback and suggested a	three months
Improvements of home monitoring	· By means of PDCA cycli, the lessons learned and feedback will have led to adjustment and improvement of the ICU-Recover Box, from its content and its use to data acquisition and data analysis.	three months

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Investigators: Principal Investigator: Sesmu Arbous, MD PhD, LUMC

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: November 11, 2022
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: E-health; User experience; Home monitoring devices; Smartphone-enabled; Health monitoring devices; Smart devices
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: NL81044.058.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data obtained through this study may be provided to qualified researchers with academic interest in home monitoring of ICU survivors. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a data transfer agreement) are prerequisites to the sharing of data with the requesting party.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. This is subject to individual patient consent.
• IPD Sharing Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). This is also subject to individual patient consent. For more information or to submit a request, the principal investigator or a member of the research team can be contacted.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No