Follow-up of Bariatric Surgery by Teleconsultations

Obesity Clinical Trial

— TELECHIRO  

Official title:

Using Tele-evaluation and Teleconsultation Instead of Classical Consultation for the Follow-up of Obese Patients After Bariatric Surgery : a Pilot Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04497259
• Other study ID #: RC31/19/0128
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2023
• Est. completion date: February 26, 2025

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: Patrick RITZ, MD
• Phone: 05 61 32 30 48
• Email: ritz.p[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: February 26, 2025
• Est. primary completion date: February 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Teleevaluation
Patients will answer to a questionnaire filled through a chatbot link
• Teleconsultation
A teleconsultation (skype-like connection) at 6 and 9 months after surgery
• Classical consultation
Patients in the consultation arm will benefit from a classical face to face consultation at 6 and 9 months after surgery.

Locations

Country	Name	City	State
France	Ritz	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite score research	Look for the composite follow-up quality score taking into account weighting results, co-morbidities, absence of complications and skill acquisition.	month 12
Secondary	Coefficient evaluation	Coefficient of variation and Cronbach's coefficient assessing the quality of the composite follow-up quality score	month 12
Secondary	Consultation measure	the time of a teleconsultation and a face-to-face consultation, by an objective measurement of this time at 6 and 9 months postoperatively	month 6 and 9
Secondary	Composite distribution	the distribution of each of the components of the Composite Follow-up Quality Score in the two arms of the study	month 12
Secondary	Consultation feeling	satisfaction and constraints felt with regard to teleconsultations, by scores measured at teleconsultations and consultation at 6 and 9 months post-operatively	Month 6 and 9
Secondary	Consultation feasability	the feasibility of teleconsultation and consultation with scores measured at 6 and 9 months post-operatively	month 6 and 9