Critically IllNCT05766319
The ICU-recover Box, Using Smart Technology for Monitoring Health Status After ICU Admission
A study testing Withings ScanWatch, Withings BPM Connect and Withings Body in people with Critically Ill and ICU Survivor, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, ICU Survivor, User Experience
- What is being tested?
- Withings ScanWatch, Withings BPM Connect and Withings Body
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Sep 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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..
Who cannot join
- 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.
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- Patient is considered an incapacitated adult.
- Patient is unwilling to sign the informed consent form.
- Patient is discharged to another hospital.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
About this study
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.
Read the 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.
- Conditions
- Critically Ill, ICU Survivor, User Experience
- Being tested
- Withings ScanWatch, Withings BPM Connect, Withings Body
- Keywords
- E-health, Home monitoring devices, Smartphone-enabled, Health monitoring devices, Smart devices, User experience
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withings ScanWatchDevice
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)
Withings BPM ConnectDevice
Withings BPM connect, from which the following feature will be used:
- Measurement of non invasive bloodpressure (mmHg)
Withings BodyDevice
Withings Body (Scale), from which the following feature will be used:
- Measurement of body weight (kg)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Withings ScanWatch; Device: Withings BPM Connect; Device: Withings Body |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: three months
Feasibility of using home monitoring devices in terms of data analyzability
- We were able to analyse the acquired data (using Python).
Measured: 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
Measured: six months
Secondary outcomes (2)
Acceptability of home monitoring
Secondary endpoints are:
- Users, i.e. post-ICU patients, have been asked, by short interviews, for feedback and suggested a
Measured: 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.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start26 Sep 2022
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sesmu M. Arbous, MD PhD MSc, Leiden University Medical Center
- Investigators
- Sesmu Arbous, MD PhD, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766319
- Sponsor's protocol ID
- NL81044.058.22
- Status last verified
- Jun 2024
- First submitted
- 11 Nov 2022
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ICU-recover Box, Using Smart Technology for Monitoring Health Status After ICU Admission
- ClinicalTrials.gov ID
- NCT05766319
- Acronym / sponsor ID
- NL81044.058.22
- Conditions
- Critically Ill, ICU Survivor, User Experience
- Keywords
- E-health, Home monitoring devices, Smartphone-enabled, Health monitoring devices, Smart devices, User experience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Patients receiving the ICU-recover box containing home monitoring devices | Experimental | Device: Withings ScanWatch, Device: Withings BPM Connect, Device: Withings BodyTreatment 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Withings ScanWatchWithings 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 | Patients receiving the ICU-recover box containing home monitoring devices |
| Withings BPM ConnectWithings BPM connect, from which the following feature will be used: o Measurement of non invasive bloodpressure (mmHg) | Device | Patients receiving the ICU-recover box containing home monitoring devices |
| Withings BodyWithings Body (Scale), from which the following feature will be used: o Measurement of body weight (kg) | Device | Patients receiving the ICU-recover box containing home monitoring devices |
Primary outcome
Feasibility of using home monitoring devices in terms of patient number
Time frame: three months
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.
Feasibility of using home monitoring devices in terms of data acquisition
Time frame: three months
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
Feasibility of using home monitoring devices in terms of data storage
Time frame: three months
· We were able to store the acquired data in a safe manner in the datasafe of the LUMC
Feasibility of using home monitoring devices in terms of data analyzability
Time frame: three to six months
· We were able to analyse the acquired data (using Python).
Feasibility of using home monitoring devices
Time frame: six months
· · > 80 % of the persons that were discharged with an ICU-Recover Box contributed for three months to post-ICU data
2 secondary outcomes
Acceptability of home monitoring
Time frame: three months
Improvements of home monitoring
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sesmu Arbous, MD PhD principal investigator
LUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Withings ScanWatch, Withings BPM Connect and Withings Body in people with Critically Ill and ICU Survivor, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of using home monitoring devices in terms of patient number (time frame: three months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.