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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Monitoring by MultiSense
  The MultiSense device will be placed on the patient's back and will allow physicians to remotely monitor six biological parameters

Первичные конечные точки

• The percentage of patients whose care was deemed satisfactory [Срок оценки: 7 days]

Вторичные конечные точки (12)

• Average length of initial hospital stay following surgery [Срок оценки: 7 days]
• Percentage of patients requiring unscheduled care related to surgery at 30 days [Срок оценки: 30 days]
• Percentage of patients with at least one unplanned rehospitalization following telemonitoring and at 30 days [Срок оценки: 30 days]
• Percentage of patients with at least one visit to the emergency department following telemonitoring and at day 30 [Срок оценки: 30 days]
• Percentage of patients with at least one grade 3 to 5 complication according to the Clavien-Dindo classification at 30 days [Срок оценки: 30 days]
• Number of unplanned rehospitalizations and/or emergency department visits at 30 days (total and per patient) [Срок оценки: 30 days]
• Number of unscheduled visits (to a general practitioner or a surgeon) at 30 days (total and per patient) [Срок оценки: 30 days]
• Quality of postoperative recovery using the French version of the fQoR-15 scale at hospital discharge (V2) and at 30 days (V4) [Срок оценки: 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) [Срок оценки: 30 days]
• Total length of hospital stay (initial admission and readmission) at 30 days [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 4th day]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 4 центра

• Western Cancer Institute of Angers — Angers
• Bergonié Insititute — Bordeaux
• Inter-municipal Hospital Centre of Mont-de-marsan — Mont-de-Marsan
• Western Cancer Institute of Nantes — Nantes

Идентификаторы

NCT: NCT07514286 · 2025 - 02 · N° IDRCB: 2025-A02326-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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