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Evaluation of a Telemedicine System for Patients Carried for Bariatric Surgery (Bartélémis)

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ClinicalTrials.gov Identifier: NCT03834181
Recruitment Status : Not yet recruiting
First Posted : February 7, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
IHU Strasbourg

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Device: Monitoring evaluation by connected devices: Wristband activity tracker "Garmin Vivosmart® 3", "Fora® Scale 550", "Terraillon® Tensioscreen", Pulse oximeter "Nonin® 3230", thermometer "Fora® IR20b" Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of a Telemedicine System for Patients Carried for Bariatric Surgery
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Monitoring evaluation
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"

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




Primary Outcome Measures :
  1. Reliability of a remote monitoring system during treatment for bariatric surgery evaluated in days between two failures [ Time Frame: From the inclusion to 6 months after the surgery ]
    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.


Secondary Outcome Measures :
  1. Patient acceptance of adding a telemonitoring device to their care evaluated in percentage of patients who signed a consent [ Time Frame: Inclusion period of 4 months ]
    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.

  2. 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 [ Time Frame: Study duration of 18 months ]
    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.

  3. Durability of the data over a defined period evaluated in number of connections. [ Time Frame: From the inclusion to 6 months after the surgery ]
    The durability of the data corresponds to the number of connections interrupted or lost in a duration of more than 90 minutes per patient

  4. Ratio of the number of patients who performed all the prescribed autonomic measures requested on the total number of patients included in the study [ Time Frame: Study duration of 18 months ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient (s) applying for bariatric surgery
  2. Patient aged 18 to 65
  3. 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
  4. Patient with an ASA (American Society of Anesthesiologists) score less than or equal to 2
  5. Patient able to receive and understand information about the study
  6. Patient able to manipulate connected objects
  7. Patient (e) affiliated to the French social security system
  8. Patient who does not live in the white area of wireless telephone coverage.

Exclusion Criteria:

  1. Patient unable to give informed consent
  2. Patient unable to use the connected tools (Internet)
  3. Patient whose general condition is not favorable to participation in the study
  4. Patient presenting, in the opinion of the investigator, a condition that may prevent participation in the procedures provided for in the study
  5. Patient in exclusion period (determined by previous or current study)
  6. Patient under the protection of justice
  7. Patient under guardianship or trusteeship
  8. Patient with epilepsy
  9. Patient who is sensitive to light flashes
  10. Patient with deformity of the ear
  11. Patient with bleeding ear

Exclusion Criteria :

  1. Patient whose home is in a white GSM (Global System for Mobile Communications) zone or white zone in reception and 3G (third generation) transmission
  2. Patient (e) not knowing how to use connected objects.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834181


Contacts
Contact: Armelle Takeda, PhD 0033390413608 armelle.takeda@ihu-strasbourg.eu

Locations
France
Service de Chirurgie Digestive et Endocrinienne, NHC Not yet recruiting
Strasbourg, France, 67 091
Contact: Michel Vix, MD    +(33) 3 69 55 10 52    michel.vix@ircad.fr   
Sponsors and Collaborators
IHU Strasbourg
Investigators
Principal Investigator: Michel Vix, MD Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg

Publications:

Responsible Party: IHU Strasbourg
ClinicalTrials.gov Identifier: NCT03834181     History of Changes
Other Study ID Numbers: 18-003
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by IHU Strasbourg:
Connected devices
Telemetry
Obesity surgery