Evaluation of a Telemedicine System for Patients Carried for Bariatric Surgery

Study Overview
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Brief Summary
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This study is intended to study the feasibility of a telemedicine system to monitor and control certain vital parameters before and after surgery for obesity. During the preoperative preparation phase, weight, exercise, blood pressure and heart rate are recorded and transmitted to the patient's surgeon. In the immediate post operative period, the heart rate is a sensitive and reliable indicator of the occurrence of a complication. A telemetry system will allow rapid home return, continuous monitoring and early warning in the event of a problem. Prolonged follow-up identical to that started preoperatively should allow improvement and better control of weight loss by monitoring especially physical exercise.

Detailed Description
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The evolution of the health system requires a rationalization of the supply of care and the care of patients. It has allowed the evolution and generalization of ambulatory surgery for certain pathologies. For other pathologies, a hospital stay is still desirable with a tendency to decrease the length of stay. Thanks to the telemedicine platforms, specialized medical monitoring can be extended pre- and post-operatively to ensure good patient preparation and quality secure follow-up. Early return to home is an essential parameter in optimizing the distribution of hospital resources. Several studies have shown improved clinical outcomes, fewer complications, more beds available, and lower hospital costs. The development of outpatient surgery has enabled the establishment of systems allowing a return home in secure conditions. Early return home is also a wish of the patient. He becomes an actor of his own health. Obesity surgery is an exemplary specialty for the care of patients. The ideal course of care is perfectly codified both preoperatively and postoperatively. Nevertheless, this ideal care path is not always respected especially in structures too small to offer a real integrated multidisciplinary follow-up. Pre- and postoperative management solutions on the Internet exist but require a voluntary and active adherence of the patient. They allow a stronger involvement of the patient in his approach, they are nascent and integrate no connected solution for automated monitoring of the patient. Telemedicine can now allow continuous monitoring without the need for face-to-face interaction. The automatic collection of the physical activity and the heart rate makes it possible to guarantee the involvement of the patient in his preparation. After the intervention, the monitoring of the occurrence of complications can be delegated to connected objects with alert transmission according to parameters defined in advance. In particular, the heart rate is a sensitive indicator and will be followed by two sensors (activity bracelet and pulse oximeter). These complications occur mainly in the 15 days following the intervention, they are rare in immediate postoperative. The hospital stay is no longer necessary for a simple surveillance. In case of receipt of an alert, the surgeon contacts the patient to check his state of health. An adapted action is then engaged. The late postoperative follow-up throughout this document corresponds to the phase following the immediate postoperative phase. This late postoperative follow-up can be improved with the support of telemonitoring (activity, change in weight.) The addition of connected devices allows a stronger and faster interaction between the patient and his doctors, providing close monitoring and appropriate support. The study focuses on assessing the reliability of a remote monitoring system. The implementation of this remote monitoring system is subordinated to the reliability of the data transmissions between the connected objects and the remote site which receives the data, interprets them and generates the alerts. The motivation of the patient is appreciated by the acceptance of connected objects. During this study, the remote monitoring system is offered in addition to the usual care. The usual care does not change and is not impaired. This study concerns only one group of patients, there is no control group since the investigators seek to validate the reliability of remote surveillance.

Official Title
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Evaluation of a Telemedicine System for Patients Carried for Bariatric Surgery

Conditions
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Bariatric Surgery Candidate

Intervention / Treatment
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* Device: Monitoring evaluation by connected devices: Wristband activity tracker Garmin Vivosmart® 3, Fora® Scale 550, Terraillon® Tensioscreen, Pulse oximeter Nonin® 3230, thermometer Fora® IR20b


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient (s) applying for bariatric surgery Patient aged 18 to 65 Compliance with the High Authority of Health (HAS) criteria: BMI> 40 without comorbidities BMI> 35 with cardiovascular, metabolic, respiratory or rheumatic comorbidity, Psychological follow-up well followed for 4 to 6 months Patient with an ASA (American Society of Anesthesiologists) score less than or equal to 2 Patient able to receive and understand information about the study Patient able to manipulate connected objects Patient (e) affiliated to the French social security system Patient who does not live in the white area of wireless telephone coverage. Exclusion Criteria: Patient unable to give informed consent Patient unable to use the connected tools (Internet) Patient whose general condition is not favorable to participation in the study Patient presenting, in the opinion of the investigator, a condition that may prevent participation in the procedures provided for in the study Patient in exclusion period (determined by previous or current study) Patient under the protection of justice Patient under guardianship or trusteeship Patient with epilepsy Patient who is sensitive to light flashes Patient with deformity of the ear Patient with bleeding ear Exclusion Criteria : Patient whose home is in a white GSM (Global System for Mobile Communications) zone or white zone in reception and 3G (third generation) transmission Patient (e) not knowing how to use connected objects.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monitoring evaluation<br>Monitoring evaluation by connected devices: Wristband activity tracker Garmin Vivosmart® 3, Fora® Scale 550, Terraillon® Tensioscreen, Pulse oximeter Nonin® 3230, thermometer Fora® IR20b | Device: Monitoring evaluation by connected devices: Wristband activity tracker Garmin Vivosmart® 3, Fora® Scale 550, Terraillon® Tensioscreen, Pulse oximeter Nonin® 3230, thermometer Fora® IR20b<br>* All patients will be monitored before and after the bariatric surgery: During the preoperative preparation phase: weight, exercise, blood pressure and heart rate In the immediate post operative period: continuous monitoring of the heart rate with a telemetry system Prolonged follow-up: weight, exercise, blood pressure and heart rate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability of a remote monitoring system during treatment for bariatric surgery evaluated in days between two failures | The reliability of the system, corresponding to the average time between two failures, over the 9 months of study for each of the 30 patients. A failure is a momentary and abrupt loss of the ability of the system to transmit data. | From the inclusion to 6 months after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient acceptance of adding a telemonitoring device to their care evaluated in percentage of patients who signed a consent | Acceptance is the ratio of the number of patients who signed the consent to the number of total patients to whom the study was presented as a percentage. | Inclusion period of 4 months | 
| Relevance of the data received from each connected object (activity bracelet, scales, blood pressure monitor, thermometer and pulse oximeter) evaluated in percentage of data sent and verified | The relevance of the data corresponds to the number of data sent and verified, using the alert system, of each of the connected objects (activity bracelet, scales, blood pressure monitor, thermometer and pulse oximeter) the number of data sent by the system over the entire duration of the study (activity bracelet, scale, tensiometer) or the entire immediate postoperative period (thermometer, pulse oximeter), in percentage. | Study duration of 18 months | 
| Durability of the data over a defined period evaluated in number of connections. | The durability of the data corresponds to the number of connections interrupted or lost in a duration of more than 90 minutes per patient | From the inclusion to 6 months after the surgery | 
| Ratio of the number of patients who performed all the prescribed autonomic measures requested on the total number of patients included in the study | Ratio of the number of patients who performed all the prescribed autonomic measures requested on the total number of patients included in the study, as a percentage. It will be evaluated by age categories (18-24, 25-34, 35-44, 45-54, 54-65 years), sex (male and female) and obesity classes (35.00 ≤ BMI). ≤ 39.99 kg / m² and BMI ≥ 40.00 kg / m²) | Study duration of 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Connected devices, Telemetry, Obesity surgery