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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorRhythm Diagnostic Systems

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: MSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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 : 1. A shorter-than-average stay (below the 75th percentile). 2. No emergency readmission or ER visit within 7 days of going home."

Time frame
7 days

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

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

Time frame
30 days
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

Other outcomes

1

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

Time frame
A 30-days period
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

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

Time frame
On the 5th day and 30th day

Sponsors and contacts

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