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| Name | Class |
|---|---|
| Calypse | UNKNOWN |
| BPIfrance | OTHER |
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The SENSE-ECO study is a prospective, randomized trial of 490 high-risk patients designed to show that the MultiSense® remote monitoring patch safely reduces hospital stays following major digestive surgery. By continuously tracking vital signs for five days at home, the device aims to maintain clinical safety and quality of life while decreasing overall healthcare costs for the French medical system.
SENSE-ECO study is a prospective, multicenter, randomized open-label trial designed to evaluate the clinical and medico-economic impact of the MultiSense® remote monitoring solution for 490 high-risk patients (ASA 2 or 3) undergoing major digestive surgery. The primary objective is to demonstrate that using this Class IIa wearable patch to monitor vital signs-such as heart rate, $SpO_2$, and respiratory rate-allows for a reduced initial hospital stay without increasing 30-day morbidity compared to standard care. In the experimental group, patients are equipped with the device 12 to 24 hours before discharge to continue continuous home monitoring for five days, while the study also assesses secondary factors including cost-effectiveness for the French healthcare system, patient quality of life via the fQoR-15 questionnaire, and organizational workload for medical staff. Conducted across five centers under the coordination of Dr. Ugo Marchese.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MultiSense® group | Experimental | Patients wearing the multisense® patch |
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| Standard group | No Intervention | Patients following the standard care pathway |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monitoring by MultiSense® | Device | The MultiSense device will be placed on the patient's back and will allow physicians to remotely monitor six biological parameters |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean CCI score of the Detailed Complications Index, calculated on the basis of complications recorded according to the Clavien-Dindo classification over a 30 day postoperative period for each of the two groups: the MultiSense group and Standard group | The Clavien-Dindo classification is a system used in surgery to classify postoperative complications according to their severity | 30 days |
| The average length of the initial stay for both groups | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Average CCI score from the Detailed Complications Index, calculated based on complications recorded according to the Clavien-Dindo classification over 8days, 15days, 30days and 90days post-surgery for each of the two groups: MultiSense® grp & Standad grp | Secondary "clinical" outcome measures | 8days, 15days, 30days and 90days |
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Inclusion Criteria :
Exclusion Criteria :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nice | Not yet recruiting | Nice | Alpes-Maritimes | 06000 | France |
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490 patients in total : 245 patients will wear the multisense patch and 245 will receive standard care
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| Average number of deaths in each arm over 8 days, 15 days, 30 days and 90 days |
Secondary "clinical" outcome measures |
| 8 days, 15 days, 30 days and 90 days |
| Average total cumulative length of stay over 30 days | Secondary "clinical" outcome measures | 30 days |
| Average number of hospital readmissions among patients receiving MultiSense® compared with patients receiving standard care, over a 30 days period; severity of the patient at readmission assessed using the Clavien-Dindo classification | Secondary "clinical" outcome measures | 30 days |
| Patient quality of life scores assessed at baseline, on discharge from hospital and at 30 days using the fQoR-15 questionnaire | Secondary "clinical" outcome measures Assess the impact on patient's quality of life fQoR-15 : French Quality of Recovery-15 15 : corresponds to the 15 multidimensional questions that make up the score. The total score ranges from 0 to 150 The higher the score, the better the quality of post-operative recovery High score = optimal recovery Low score = impaired recovery | 30 days |
| Total 30-day healthcare costs (€) and cost-effectiveness comparing outcome differences between groups, including morbidity, length of stay, readmissions, patient severity, staff satisfaction, quality of life, and organisational impact. | Secondary "medico-economic" outcome measures | 30 days |
| Net benefit to the healthcare system (€) from the roll-out of the Multisense solution in France (difference between incurred and avoided costs) over 4 years | Secondary "medico-economic" outcome measures | 4 years |
| Average daily time (hours and minutes) spent on the platform by the remote monitoring team to monitor patients in the MultiSense group (collected via the MultiSense platform) | Secondary "organisational impact" outcome measures | Daily during the 5 days remote monitoring period following hospital discharge |
| Average number of incoming and outgoing calls per patient in both groups within 30 days of surgery | Secondary "organisational impact" outcome measures | 30 days |
| Table of activities and stakeholders enabling a comprehensive identification of the roles of the various parties involved in post-operative monitoring within each group | Secondary "organisational impact" outcome measures | Up to 30 days post-surgery |
| Levels of satisfaction 30 days post-operation, as reported by healthcare professionals (surgeons and paramedical staff involved in patient follow-up) and by patients, assessed using ad hoc questionnaires designed for the study | Secondary "organisational impact" outcome measures | 30 day |
| Assessment of the usability of the MultiSense® solution for healthcare professionals involved in post-operative follow-up, using the F-SUS scale completed at the end of the study | Secondary organisational impact outcome measures F-SUS : French version of the System Usability Scale Minimum value : 0 Maximum value : 100 Interpretation of the score : A high score indicates a positive result. The closer the score is to 100, the more the system (in this case, the MultiSense® solution) is considered to be user-friendly, intuitive and satisfactory for healthcare professionals. Conversely, a low score indicates poor usability. | 18 months |
| Percentage of patients non-compliant with remote monitoring via MultiSense® (non-compliance is defined as discontinuation of monitoring before 80% of the scheduled duration has elapsed, which corresponds to the fourth day) | Secondary "organisational impact" outcome measures | 4th day |
| CHU de Besançon | Not yet recruiting | Besançon | Doubs | 25000 | France |
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| CHU Charles-Nicolle | Not yet recruiting | Rouen | Seine-Maritime | 76000 | France |
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| CHU Amiens-Picardie | Not yet recruiting | Amiens | 80000 | France |
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| Hôpital Cochin, AP-HP Centre | Recruiting | Paris | 75014 | France |
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