Follow-up of Bariatric Surgery by Teleconsultations (TELECHIRO)

Toulouse University Hospital

Status: Enrolling

Conditions: Obesity

Treatments: Other: Classical consultation; Other: Teleevaluation; Other: Teleconsultation

Study type: Interventional

Funder types: Other

Identifiers

NCT04497259

RC31/19/0128

Details and patient eligibility

About

An organised follow-up is required after bariatric surgery, but 50% of patients are lost to follow-up after 2 years. To design a large randomized clinical trial (RCT) comparing teleevaluations and teleconsultations to classical follow, aiming to prove that the quality of the follow-up is maintained and the patient-experience is improved, at a lower cost in people living far from the reference centre, this pilot study aims at describing the distribution of the collected criteria.

Full description

An organised follow-up is required after bariatric surgery, but 50% of patients are lost to follow-up after 2 years. This follow-up requires about 5 multi-professional evaluations during the first year. This can be cumbersome in patients living far from the reference centre and who may perceive the necessary time, cost and lost of income, and constraints as imbalanced. Teleevaluations and teleconsultations may solve this issue by replacing some of the classical evaluations (at 6 and 9 months). An RCT would be necessary, and a pilot study is proposed to describe the distribution of the judgment criteria.

This pilot study aims at describing all the parameters necessary to build an RCT, and involves the randomisation of operated patients recruited 3 months after surgery, in to groups. One will have the classical follow-up (venue and consultations at 6 and 9 months) the over will have teleevaluations and teleconsultations ; the parameters will be described at 12 months. The teleevaluation is either proposed as usual (a file is sent by secure mail) or by chatbot interaction. The consultation and the teleconsultation are based on the standard of care scenario.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adults having had bariatric surgery 3 months before
• able to use an internet tool of chatbot and skype-like secured connection
• adult under 60 years old
• free inform and sign consent
• living more than 50km from Toulouse
• persons with social security

Exclusion criteria

• complications at the 3rd month post-surgery requiring specific care
• insufficient internet connection
• minor
• pregnant women
• protected adults
• people in emergency
• people unable to give consent

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Interventional

Experimental group

Description:

Patients in the teleconsultation arm will benefit from a tele-evaluation (a questionnaire filled through a chatbot link) and teleconsultation (skype-like connection) at 6 and 9 months after surgery.

Treatment:

Other: Teleconsultation

Other: Teleevaluation

Control

Experimental group

Description:

Patients in the consultation arm will benefit from a tele-evaluation (a questionnaire filled at home after the file was sent by secured mail) and a classical face to face consultation at 6 and 9 months after surgery.

Treatment:

Other: Teleevaluation

Other: Classical consultation