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

NCT05766319 | Completed

• 1 other identifier: NL81044.058.22
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill; ICU Survivor; User Experience

Keywords

E-health; Home monitoring devices; Smartphone-enabled; Health monitoring devices; Smart devices; User experience

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Acceptability of home monitoring

  three months

• Improvements of home monitoring

  three months

Study Arms (1)

Patients receiving the ICU-recover box containing home monitoring devices

EXPERIMENTAL

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)

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

Interventions

Withings ScanWatch DEVICE

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)

Patients receiving the ICU-recover box containing home monitoring devices

Withings BPM Connect DEVICE

Withings BPM connect, from which the following feature will be used: o Measurement of non invasive bloodpressure (mmHg)

Patients receiving the ICU-recover box containing home monitoring devices

Withings Body DEVICE

Withings Body (Scale), from which the following feature will be used: o Measurement of body weight (kg)

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:

• 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..

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sesmu Arbous, MD PhD

  LUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr.

Model Details: 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

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: March 13, 2023
• Study Start: September 26, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

NL (1)