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

Surgery Clinical Trial

— SMART ANGEL 1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464721
• Other study ID #: IDIL/2017/PC-01
• Status: Completed
• Start date: May 14, 2018
• Est. completion date: September 28, 2018

Study information

• Verified date: January 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 28, 2018
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• issued with SMART ANGEL device
patients will use the technology at home to record and transmit data for blood pressure and oxygen saturation

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation	Data collected and transmitted	Day 0
Primary	Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation	Data collected and transmitted	Day 1
Primary	Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation	Data collected and transmitted	Day 2
Primary	Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation	Data collected and transmitted	Day 3
Primary	Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation	Data collected and transmitted	Day 4
Primary	Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation	Data collected and transmitted	Day 5
Primary	Concordance between data collected on tablet versus paper copies	Percentage correct measures	Day 0
Primary	Concordance between data collected on tablet versus paper copies	Percentage correct measures	Day 1
Primary	Concordance between data collected on tablet versus paper copies	Percentage correct measures	Day 2
Primary	Concordance between data collected on tablet versus paper copies	Percentage correct measures	Day 3
Primary	Concordance between data collected on tablet versus paper copies	Percentage correct measures	Day 4
Primary	Concordance between data collected on tablet versus paper copies	Percentage correct measures	Day 5
Secondary	Ease of use of medical device according to patient	System Usability Scale (SUS) : score 0-100	Day 5
Secondary	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
Secondary	Readmission rate	Percentage of patients readmitted to hospital	Month 1
Secondary	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