Clinical trial NCT04497259: Follow-up of Bariatric Surgery by Teleconsultations
Official title: Using Tele-evaluation and Teleconsultation Instead of Classical Consultation for the Follow-up of Obese Patients After Bariatric Surgery : a Pilot Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: bariatric surgery
follow-up
tele-evaluations
e-medicine
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Composite score research
timeFrame: month 12
Secondary outcomes:
measure: Coefficient evaluation
timeFrame: month 12
measure: Consultation measure
timeFrame: month 6 and 9
measure: Composite distribution
timeFrame: month 12
measure: Consultation feeling
timeFrame: Month 6 and 9
measure: Consultation feasability
timeFrame: month 6 and 9
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Ritz
Study officials:
affiliation: University Hospital, Toulouse
name: Patrick RITZ, Md
role: PRINCIPAL_INVESTIGATOR
References: