Assessment of the Feasibility and Organisational Impact of a Care Pathway Incorporating the MultiSense® Medical Device for Post-operative Home Monitoring of Elderly Patients. (IMPACT - MS)

Assessing the clinical and organisational impact of a home-based post-operative monitoring strategy incorporating the MultiSense® device involving 80 patients aged 65 years and over who have undergone major surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery; Average Length of Stay
• Intervention / Treatment: Device: Monitoring by MultiSense

Detailed Description

Evaluate the clinical and organisational impact of a post-operative home monitoring strategy incorporating the MultiSense® device in elderly patients.

The study will be conducted in a multicentre setting, involving 80 patients aged 65 years and over who have undergone major surgery.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49000
    • Western Cancer Institute of Angers
    • Contact: Dr Augustin REYNARD, Gynaecological Oncology Surgeon; Phone Number: +33 2 41 35 29 02; Email: augustin.reynard@ico.unicancer.fr
  • Bordeaux, France, 33000
    • Bergonié Insititute
    • Contact: Dr Brice RICHEZ, Anaesthetist and intensive care specialist; Phone Number: +33 5 56 33 32 40; Email: b.richez@bordeaux.unicancer.fr
  • Mont-de-Marsan, France, 40000
    • Inter-municipal Hospital Centre of Mont-de-marsan
    • Contact: Dr Rémy CHEVALIER, Visceral and digestive surgeon; Phone Number: +33 5 58 05 10 09; Email: remy.chevalier@ch-mdm.fr
  • Nantes, France, 44000
    • Western Cancer Institute of Nantes
    • Contact: Dr Timothée VIGNAUD, Visceral and digestive surgeon; Phone Number: +33 2 40 67 99 00; Email: Timothee.vignaud@ico.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria :

• Patient aged 65 or over
• Patient eligible for remote monitoring using the MultiSense® device
• No psychiatric illness that would prevent them from giving informed consent or receiving optimal treatment and follow-up care
• Subject affiliated with a health insurance scheme
• Subject able to read and understand English
• Subject who has signed an informed consent form
• Subjects indicated for scheduled surgery

• Patients indicated for scheduled surgery :

  • Transverse colectomy, by laparotomy
  • Hepatic laparoscopy
  • Laparoscopic or laparoscopic liver surgery (code hlfc or hlfa for procedures)
  • Hysterectomy
  • Adnexectomy
  • Parietal surgery (eventration)
  • Rectal resection
  • Right and left colectomy
  • Stoma closure by direct approach

Exclusion Criteria :

• Patients already participating in an interventional clinical trial.
• Patients subject to legal protection measures, guardianship, curatorship, or deprived of their liberty by judicial or administrative decision.
• Patients hospitalised without consent.
• Patients unable to complete a questionnaire and without a close relative to assist them in using the solution.
• Patients admitted to or residing in a health or social care facility (other than for the surgery itself).
• Persons admitted to or residing in a health or social care institution (other than for the surgery itself);
• Persons unable to give their free and informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MS; All patients will be monitored at home with the medical device MultiSense®	Device: Monitoring by MultiSense; The MultiSense device will be placed on the patient's back and will allow physicians to remotely monitor six biological parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of patients whose care was deemed satisfactory	The quality of surgical care will be assessed using a "textbook outcome" (TO) composed of the 2 following criteria : A shorter-than-average stay (below the 75th percentile).; No emergency readmission or ER visit within 7 days of going home."	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average length of initial hospital stay following surgery		7 days
Percentage of patients requiring unscheduled care related to surgery at 30 days	Patients requiring unplanned readmission and/or a visit to the emergency department	30 days
Percentage of patients with at least one unplanned rehospitalization following telemonitoring and at 30 days		30 days
Percentage of patients with at least one visit to the emergency department following telemonitoring and at day 30		30 days
Percentage of patients with at least one grade 3 to 5 complication according to the Clavien-Dindo classification at 30 days	The Clavien-Dindo classification is a system used in surgery to classify postoperative complications according to their severity	30 days
Number of unplanned rehospitalizations and/or emergency department visits at 30 days (total and per patient)		30 days
Number of unscheduled visits (to a general practitioner or a surgeon) at 30 days (total and per patient)		30 days
Quality of postoperative recovery using the French version of the fQoR-15 scale at hospital discharge (V2) and at 30 days (V4)	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
Measurement of the overall index score for the EQ-5D-5L questionnaire at preoperative assessment (V0), at hospital discharge (V2), and at 30 days (V4)	Assess the impact on patients' quality of life EQ : EuroQol, the name of the international research group that developed this tool. 5D : 5 dimensions of health assessed (mobility, independence, daily activities, pain/discomfort, and anxiety/depression). 5L : 5 levels, the 5 possible severity levels for each dimension : Level 1 : No difficulty (or no problems).; Level 2 : Mild problems.; Level 3 : Moderate problems.; Level 4 : Severe problems.; Level 5 : Total disability (or extreme problems). A higher score indicates better health	30 days
Total length of hospital stay (initial admission and readmission) at 30 days	Assess the organizational impact associated with the deployment of the MULTISENSE® solution based on the HAS's mapping	30 days
DAOH30 (Days Alive and Out of Hospital) or Days of Independence at Home at Day 30, defined as the number of days during which the patient recovered independently at home without requiring hospitalization or rehospitalization, during the 30-day postoper	This outcome will be calculated using the following formula : DAOH30 = 30 days - (initial length of stay + duration of readmissions)	30 days
Percentage of patients who did not comply with remote monitoring via MultiSense® (non-compliance is defined as the patient discontinuing monitoring before reaching 80% of the scheduled duration, which corresponds to the 4th day)	Assess patient and healthcare professional satisfaction with and usability of the solution	4th day
Average usability score reported by healthcare professionals using the French version of the SUS (System Usability Scale) questionnaire completed at the end of the study	SUS : 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.	8 months
Level of patient satisfaction as measured by a specific questionnaire completed following the remote monitoring session	This is an 'ad hoc' satisfaction questionnaire (specifically designed for the purposes of this study). Scale details : The full name given in the appendix is the Patient Satisfaction Questionnaire. It assesses levels of satisfaction with the MultiSense® solution. Scores and interpretation : the exact minimum and maximum scores are not specified, a high score corresponds to a positive result (greater patient satisfaction).	5th day
Level of healthcare professionals' reassurance regarding the patient's return home, assessed by a questionnaire completed at the time of discharge.	This is an 'ad hoc' satisfaction questionnaire (specifically designed for the purposes of this study). Scale details : The full name given in the appendix is the Patient Satisfaction Questionnaire. It assesses levels of satisfaction with the MultiSense® solution. Scores and interpretation : the exact minimum and maximum scores are not specified, a high score corresponds to a positive result (greater patient satisfaction).	Day 1
Level of satisfaction among healthcare professionals, as measured by a specific questionnaire completed at the end of the study	This is an 'ad hoc' satisfaction questionnaire (specifically designed for the purposes of this study). Scale details : The full name given in the appendix is the Patient Satisfaction Questionnaire. It assesses levels of satisfaction with the MultiSense® solution. Scores and interpretation : the exact minimum and maximum scores are not specified, a high score corresponds to a positive result (greater patient satisfaction).	8 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temporal distribution of complications by severity level according to the Clavien-Dindo classification between the day of surgery and day 30	To assess the impact of the treatment pathway on the timing and severity of complications	A 30-days period
Mapping of complications according to the following classification : complications of severity 1 to 2 and complications of severity 3 or higher according to the Clavien-Dindo classification at the end of remote monitoring and at day 30	To assess the impact of the treatment pathway on the timing and severity of complications	On the 5th day and 30th day

Collaborators and Investigators

• Sponsor: Rhythm Diagnostic Systems

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Remote monitoring
• Other Study ID Numbers: 2025 - 02; N° IDRCB: 2025-A02326-43 (Other Identifier: RDS SAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No