Follow-up of Bariatric Surgery by Teleconsultations

NCT ID: NCT04497259

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-26
• Study Completion Date: 2025-02-26

Brief Summary

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.

Detailed 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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Interventional

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.

Group Type: EXPERIMENTAL

Teleevaluation

Intervention Type: OTHER

Patients will answer to a questionnaire filled through a chatbot link

Teleconsultation

Intervention Type: OTHER

A teleconsultation (skype-like connection) at 6 and 9 months after surgery

Control

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.

Group Type: EXPERIMENTAL

Teleevaluation

Intervention Type: OTHER

Patients will answer to a questionnaire filled through a chatbot link

Classical consultation

Intervention Type: OTHER

Patients in the consultation arm will benefit from a classical face to face consultation at 6 and 9 months after surgery.

Interventions

Teleevaluation

Patients will answer to a questionnaire filled through a chatbot link

Intervention Type: OTHER

Teleconsultation

A teleconsultation (skype-like connection) at 6 and 9 months after surgery

Intervention Type: OTHER

Classical consultation

Patients in the consultation arm will benefit from a classical face to face consultation at 6 and 9 months after surgery.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick RITZ, Md

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Ritz

Toulouse, Toulouse, France

Site Status: RECRUITING

Countries

France

Central Contacts

Patrick RITZ, MD

Role: CONTACT

ritz.p@chu-toulouse.fr

05 61 32 30 48 ext. +33

Facility Contacts

Patrick Ritz

Role: primary

ritz.p@chu-toulouse.fr

0561323048 ext. +33

Emilie MONTASTIER

Role: backup

Ana ESTRADE

Role: backup

Leila BOULANOUAR

Role: backup

Monelle BERTRAND

Role: backup

Other Identifiers

RC31/19/0128

Identifier Type: -

Identifier Source: org_study_id