ICU Acquired WeaknessNCT07162948
ICU-Recover Box 2.0, Smart Technology for Home Monitoring of ICU Patients
A study testing The ICU-Recover Box: using smart technology for monitoring health status after ICU admission Pilot 2.0 in people with ICU Acquired Weakness, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Acquired Weakness
- What is being tested?
- The ICU-Recover Box: using smart technology for monitoring health status after ICU admission Pilot 2.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
Sesmu Arbous, MD PhD, +3175265018, marbous@lumc.nl
Tina van Hemel-Rintjap, MD, +31715265018, J.D.van_Hemel-Rintjap@lumc.nl
About this study
Official title: The ICU-Recover Box: Using Smart Technology for Monitoring Health Status After ICU Admission Pilot Study 2.0
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.
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 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.
- Conditions
- ICU Acquired Weakness
- Being tested
- The ICU-Recover Box: using smart technology for monitoring health status after ICU admission Pilot 2.0
- Keywords
- smart technology, post-ICU recovery, post intensive care syndrome, health care utilization, health related quality of life
- Medical subject headings
- postintensive care syndrome, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The ICU-Recover Box: using smart technology for monitoring health status after ICU admission Pilot 2.0Device
The Corsano CardioWatch 287-2 measures blood pressure, heart rate, heart rate variability, respiratory rate, peripheral oxygen saturation, body temperature and their daily activity.This devices is used for personal management, never to directly base a diagnosis or treatment on. The patient has to download the Corsano App on his/her mobile phone.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving the ICU-recover box containing home monitoring devices | Other | 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. Receives: Device: The ICU-Recover Box: using smart technology for monitoring health status after ICU admission Pilot 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of smart technology
- The percentage of included post-ICU patients that was able to use and actually did use smart technology for twelve consecutive months.
Measured: 12 months
Acquisition of data
- That it was possible (y/n) to acquire the data from the remote monitoring and that the investigators were able to store and use the data for analyses
Measured: 12 months
Secondary outcomes (1)
Lessons Learnt
That the investigators have an inventory of the lessons learned and feedback from participants, collected by a predefined questionnaire. On a monthly base the investigators will contact participants and ask them: (1) 36 questions on quality of life; (2) 2 questions on health care utilization; and (3) 9 questions on the use of the Corsano equipment. The questions are customised and not part of standardised questionnaires. Some questions are open-ended, while some are scale based (almost never-almost always).
The investigators will report the results of these questionnaires qualitatively, as no final "score" can be attributed to the filled out questionnaire.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Jul 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU Acquired WeaknessStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The primary objective of this pilot study is to assess the feasibility of the use of smart technology, i.e. Corsano CardioWatch 287-2 and blood pressure monitor assembled in the so-called ICU-Recover Box, by persons that have been discharged from the ICU in the one year following hospital discharge.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162948
- Sponsor's protocol ID
- NL86464.058.24
- Status last verified
- Sep 2025
- First submitted
- 25 Jun 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. 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 Pilot Study 2.0
- ClinicalTrials.gov ID
- NCT07162948
- Acronym / sponsor ID
- NL86464.058.24
- Conditions
- ICU Acquired Weakness
- Keywords
- smart technology, post-ICU recovery, post intensive care syndrome, health care utilization, health related quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Sep 2025 (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.
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.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The primary objective of this pilot study is to assess the feasibility of the use of smart technology, i.e. Corsano CardioWatch 287-2 and blood pressure monitor assembled in the so-called ICU-Recover Box, by persons that have been discharged from the ICU in the one year following hospital discharge.
| Arm | Type | Receives |
|---|---|---|
| Patients receiving the ICU-recover box containing home monitoring devices | Other | Device: The ICU-Recover Box: using smart technology for monitoring health status after ICU admission Pilot 2.0Treatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| The ICU-Recover Box: using smart technology for monitoring health status after ICU admission Pilot 2.0The Corsano CardioWatch 287-2 measures blood pressure, heart rate, heart rate variability, respiratory rate, peripheral oxygen saturation, body temperature and their daily activity.This devices is used for personal management, never to directly base a diagnosis or treatment on. The patient has to download the Corsano App on his/her mobile phone. | Device | Patients receiving the ICU-recover box containing home monitoring devices |
Primary outcome
Use of smart technology
Time frame: 12 months
· The percentage of included post-ICU patients that was able to use and actually did use smart technology for twelve consecutive months.
Acquisition of data
Time frame: 12 months
· That it was possible (y/n) to acquire the data from the remote monitoring and that the investigators were able to store and use the data for analyses
1 secondary outcome
Lessons Learnt
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The ICU-Recover Box: using smart technology for monitoring health status after ICU admission Pilot 2.0 in people with ICU Acquired Weakness, 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sesmu Arbous, MD PhD (+31715265018, marbous@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of smart technology (time frame: 12 months). The study lists 2 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 29 Sep 2025.