Critically Ill Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | August 1, 2023 |
Est. primary completion date | May 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University Medical Center | Leiden | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 |
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