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

Outpatient Clinic in Obesity Care During COVID-19 Outbreak: Physically Far, Virtually Near. Brief Correspondence on a Single Center Experience. Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate; Patient Underwent Bariatric Surgery
• Intervention / Treatment: Other: Telemedicine to remote outpatient visit in bariatric patient

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • University of Campania "Luigi Vanvitelli"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A total of 138/175 patients (78.8%) were eligible for telemedicine (66 established patients, 25 undergoing surgery within 30 days and 47 for the first time referred to our center).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of feasibility of telemedicine in outpatient visit in bariatric patients	Telemedicine to follow-up and identify sing or symptom of alarm in patient undergoing bariatric surgery or in established bariatric patients during COVID-19 outbreak	2 months

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Actual): May 4, 2020
• Study Completion (Actual): May 4, 2020

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: Telemedicine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No