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NCT Number: NCT07514286

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

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.

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Key information

Conditions

Average Length of Stay Surgery

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western Cancer Institute of Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. The percentage of patients whose care was deemed satisfactory

    Time frame: 7 days

    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."

Secondary outcomes

  1. Average length of initial hospital stay following surgery

    Time frame: 7 days

  2. Percentage of patients requiring unscheduled care related to surgery at 30 days

    Time frame: 30 days

    Patients requiring unplanned readmission and/or a visit to the emergency department

  3. Percentage of patients with at least one unplanned rehospitalization following telemonitoring and at 30 days

    Time frame: 30 days

  4. Percentage of patients with at least one visit to the emergency department following telemonitoring and at day 30

    Time frame: 30 days

  5. Percentage of patients with at least one grade 3 to 5 complication according to the Clavien-Dindo classification at 30 days

    Time frame: 30 days

    The Clavien-Dindo classification is a system used in surgery to classify postoperative complications according to their severity

  6. Number of unplanned rehospitalizations and/or emergency department visits at 30 days (total and per patient)

    Time frame: 30 days

  7. Number of unscheduled visits (to a general practitioner or a surgeon) at 30 days (total and per patient)

    Time frame: 30 days

  8. Quality of postoperative recovery using the French version of the fQoR-15 scale at hospital discharge (V2) and at 30 days (V4)

    Time frame: 30 days

    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

  9. 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)

    Time frame: 30 days

    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

  10. Total length of hospital stay (initial admission and readmission) at 30 days

    Time frame: 30 days

    Assess the organizational impact associated with the deployment of the MULTISENSE® solution based on the HAS's mapping

  11. 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

    Time frame: 30 days

    This outcome will be calculated using the following formula :

    DAOH30 = 30 days - (initial length of stay + duration of readmissions)

  12. 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)

    Time frame: 4th day

    Assess patient and healthcare professional satisfaction with and usability of the solution

  13. 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

    Time frame: 8 months

    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.

  14. Level of patient satisfaction as measured by a specific questionnaire completed following the remote monitoring session

    Time frame: 5th day

    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).

  15. Level of healthcare professionals' reassurance regarding the patient's return home, assessed by a questionnaire completed at the time of discharge.

    Time frame: Day 1

    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).

  16. Level of satisfaction among healthcare professionals, as measured by a specific questionnaire completed at the end of the study

    Time frame: 8 months

    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).

Other outcomes

  1. Temporal distribution of complications by severity level according to the Clavien-Dindo classification between the day of surgery and day 30

    Time frame: A 30-days period

    To assess the impact of the treatment pathway on the timing and severity of complications

  2. 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

    Time frame: On the 5th day and 30th day

    To assess the impact of the treatment pathway on the timing and severity of complications

Sponsors and collaborators

Lead sponsor

Rhythm Diagnostic Systems

Industry

Registry information

Acronym: IMPACT - MS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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