Outpatient Clinic in Obesity Care During COVID-19 Outbreak: Physically Far, Virtually Near

NCT ID: NCT04407663

Last Updated: 2020-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-03

Study Completion Date

2020-05-04

Brief Summary

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Bariatric patients represent a peculiar and frail subset of subjects, constantly increasing. During the novel coronavirus disease outbreak, for the lockdown of any non-urgent and non-oncological activity, the access to healthcare services was severely limited, according to the International Federation for the Surgery of Obesity and Metabolic Disorders.

Detailed Description

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The constant and strict follow-up is mandatory in this special subset of patients. Therefore, starting from the telemedicine experience in different medical fields, in our bariatric surgery division we designed and started a dedicated project to follow-up obese patients using remote counselling.

Conditions

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Bariatric Surgery Candidate Patient Underwent Bariatric Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Bariatric Patient

Inclusion criteria were as follows: obese adults (\> 18 years of age, BMI\> 40 or \> 35 with comorbidities) older than 18 years; patients undergoing bariatric surgery within 6 months; patients who required clinical and instrumental control; presence of a caregiver in case of subject with cognitive impairment; patients with a history of bariatric surgery who requested a first outpatients access or established patients who requested an outpatients' visit for an emerging problem.

Telemedicine to remote outpatient visit in bariatric patient

Intervention Type OTHER

Patients that referred for the first time to our bariatric center were investigated for anthropometric, psychological and instrumental data in order to evaluate the eligibility for a future bariatric procedure. In established patients, eligibility for tele-consultation was evaluated by three experienced physicians, consulting the stored patients' data. All included patients provided oral informed consent. Patients approached the virtual visit with their personal smart devices, desktop or laptop computer. Medical counselling was performed using a desktop or laptop computer from the Hospital or home in a smart working modality. The video call was carried out using Skype platform by Microsoft®; any document drawn up by the physician was saved as pdf using the Cute Professional™ PDF software, that allows to add passwords and set security options to protect the patients' data.

Interventions

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Telemedicine to remote outpatient visit in bariatric patient

Patients that referred for the first time to our bariatric center were investigated for anthropometric, psychological and instrumental data in order to evaluate the eligibility for a future bariatric procedure. In established patients, eligibility for tele-consultation was evaluated by three experienced physicians, consulting the stored patients' data. All included patients provided oral informed consent. Patients approached the virtual visit with their personal smart devices, desktop or laptop computer. Medical counselling was performed using a desktop or laptop computer from the Hospital or home in a smart working modality. The video call was carried out using Skype platform by Microsoft®; any document drawn up by the physician was saved as pdf using the Cute Professional™ PDF software, that allows to add passwords and set security options to protect the patients' data.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* obese adults (\> 18 years of age, BMI\> 40 or \> 35 with comorbidities) older than 18 years
* patients undergoing bariatric surgery within 6 months
* patients who required clinical and instrumental control
* presence of a caregiver in case of subject with cognitive impairment; patients with a history of bariatric surgery who requested a first outpatients access or established patients who requested an outpatients' visit for an emerging problem.

Exclusion Criteria

* virtual visit decline
* the internet or smart devices unavailability
* need for physical examination or radiological investigations established during a preliminary contact by phone.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Claudio Gambardella

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Campania "Luigi Vanvitelli"

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Telemedicine

Identifier Type: -

Identifier Source: org_study_id