The investigators hypothesize that by monitoring and analyzing physiological parameters (heart rate, blood pressure, saturation) and well-being (pain, nausea, vomiting, comfort) the SMART ANGEL ™ device improves the quality of care after major or intermediate outpatient surgery. This active surveillance will result in a decrease in the rate of unplanned recourse (hospitalization, consultation, telephone call).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
1,260
Patient issued with a tablet with the Smart Angel application to monitor clinical signs and symptoms
Clinique Bonnefon
Alès, France
Centre hospitalier universitaire Amiens-Picardie
Amiens, France
Hôpital Privé les Bonnettes
Arras, France
Centre Hospitalier Henri Duffaut
Non-scheduled hospitalization rates between groups
%
Time frame: Day 5
Number of non-scheduled consultations between groups
%
Time frame: Day 5
Rates of calls with nurses between groups
%
Time frame: Day 5
Rates of calls with doctors between groups
%
Time frame: Day 5
Rates of unplanned prescriptions between groups
%
Time frame: Day 5
Rates of unplanned exams between groups
%
Time frame: Day 5
Rate of complications between groups
% patients reported any of: nausea, vomiting, constipation, allergy, shivering, insomnia, pain, fever, sore throat, lower back pain, headache, hypotension, bradycardia, hallucination, fainting, reopening of the incision, repeated surgery, abscess, bleeding, or bruising
Time frame: Day 1
Rate of complications between groups
% patients reported any of: nausea, vomiting, constipation, allergy, shivering, insomnia, pain, fever, sore throat, lower back pain, headache, hypotension, bradycardia, hallucination, fainting, reopening of the incision, repeated surgery, abscess, bleeding, or bruising
Time frame: Day 2
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Avignon, France
CHU Lille
Lille, France
Hopital Nord
Marseille, France
Hôpital Lapeyronie
Montpellier, France
CHU de Nimes
Nîmes, France
Polyclinique Grand Sud
Nîmes, France
Institut Mutualiste Montsouris
Paris, France
...and 2 more locations
Rate of complications between groups
% patients reported any of: nausea, vomiting, constipation, allergy, shivering, insomnia, pain, fever, sore throat, lower back pain, headache, hypotension, bradycardia, hallucination, fainting, reopening of the incision, repeated surgery, abscess, bleeding, or bruising
Time frame: Day 3
Rate of complications between groups
% patients reported any of: nausea, vomiting, constipation, allergy, shivering, insomnia, pain, fever, sore throat, lower back pain, headache, hypotension, bradycardia, hallucination, fainting, reopening of the incision, repeated surgery, abscess, bleeding, or bruising
Time frame: Day 4
Rate of complications between groups
% patients reported any of: nausea, vomiting, constipation, allergy, shivering, insomnia, pain, fever, sore throat, lower back pain, headache, hypotension, bradycardia, hallucination, fainting, reopening of the incision, repeated surgery, abscess, bleeding, or bruising
Time frame: Day 5
Rate of complications between groups
% patients reported any of: nausea, vomiting, constipation, allergy, shivering, insomnia, pain, fever, sore throat, lower back pain, headache, hypotension, bradycardia, hallucination, fainting, reopening of the incision, repeated surgery, abscess, bleeding, or bruising
Time frame: Month 1
Rate of readmission between groups
Yes/No
Time frame: Month 1
Date of return to work or other activity
Dd/mm/yyyy
Time frame: 1 Month
Patient satisfaction
Visual Analog Scale 0-10
Time frame: Day 6
Patient quality of life
EQ-5D-5L questionnaire taken over the phone
Time frame: 1 month
Difficulties in using the device
In-house developed usage questionnaire assessing measurement difficulties, saving errors, connection problems, problem contacting care staff
Time frame: Day 5
Requirement of external help in using the device
Description of person sought for advice
Time frame: Day 5
Times spent on device
Hours; automatically calculated by device for time used for manipulation and time for navigation
Time frame: Day 5
Technical errors arising
Automatically calculated by device
Time frame: Day 5