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

Study Overview
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Brief Summary
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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

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

Conditions
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Surgery

Intervention / Treatment
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* Device: issued with SMART ANGEL device


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgery Outpatients<br> | Device: issued with SMART ANGEL device<br>* patients will use the technology at home to record and transmit data for blood pressure and oxygen saturation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation | Data collected and transmitted | Day 0 | 
| Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation | Data collected and transmitted | Day 1 | 
| Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation | Data collected and transmitted | Day 2 | 
| Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation | Data collected and transmitted | Day 3 | 
| Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation | Data collected and transmitted | Day 4 | 
| Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation | Data collected and transmitted | Day 5 | 
| Concordance between data collected on tablet versus paper copies | Percentage correct measures | Day 0 | 
| Concordance between data collected on tablet versus paper copies | Percentage correct measures | Day 1 | 
| Concordance between data collected on tablet versus paper copies | Percentage correct measures | Day 2 | 
| Concordance between data collected on tablet versus paper copies | Percentage correct measures | Day 3 | 
| Concordance between data collected on tablet versus paper copies | Percentage correct measures | Day 4 | 
| Concordance between data collected on tablet versus paper copies | Percentage correct measures | Day 5 | 

Secondary Outcome Measures

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