Usability of SMART ANGEL Medical Device to Record and Transmit Health Data From Patient's Home Following Outpatient Surgery

Completed

• Conditions: Surgery
• Interventions: Device: issued with SMART ANGEL device

• Registration Number: NCT03464721
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

This study represents the first step for testing this device in patients in real-life situations to evaluate the technological capacities and usability by the patient

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-14
• Study Start: 2018-05-14
• Primary Completion: 2018-09-28
• Study Completion: 2018-09-28
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan
• The patient is at least 18 years old and less than 80 years old
• The patient is undergoing orthopedic (shoulder, foot, knee), digestive (gallbladder) or gynecological (uterus-ovary) adjustment outpatient surgery
• The patient has sufficient cognitive and intellectual ability to use the system
• The patient must undergo a training test during consultation to use the tablet and perform the measurements
• The patient must have access to 4G at home.

Exclusion Criteria

• The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
• The subject refuses to sign the consent
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship
• The patient is pregnant
• The patient needs emergency surgery
• The patient has a level 4 or 5 ASA psychological class
• Patient cannot have outpatient surgery for medical reasons (decompensated medical pathology), or social reasons according the the SFAR (société française anesthésie réanimation) criteria. Patient alone at home and geographically far from a hospital >30km (or >45 minutes by car).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgery Outpatients	issued with SMART ANGEL device	-

Primary Outcome Measures

Name	Time	Method
Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation	Day 5	Data collected and transmitted
Concordance between data collected on tablet versus paper copies	Day 5	Percentage correct measures

Secondary Outcome Measures

Name	Time	Method
Qualitative decision-making ability from pooled results of all data from all patients on readmittance rate	End of inclusion period: Month 18	Group of 2 experts decide whether patients should have been readmitted based on retrospective analysis of all data
Ease of use of medical device according to patient	Day 5	System Usability Scale (SUS) : score 0-100
Readmission rate	Month 1	Percentage of patients readmitted to hospital
Qualitative decision-making ability from pooled results of all data from all patients	End of inclusion: Month 18	Group of 2 experts decide whether patients should have been hospitalized, called, or left alone based on retrospective analysis of all data

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, France