Impact of Telemonitoring on Metabolic Variables in Severe Obesity

Severe Obesity Clinical Trial

— teleob  

Official title:

The Role of Home Telemonitoring in the Evaluation of Patients With Severe Obesity After a Period of Residential Metabolic Rehabilitation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786092
• Other study ID #: 18C020
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: October 15, 2024

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: Massimo Scacchi
• Phone: +390323514301
• Email: massimo.scacchi[@]unimi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare, in a population of severely obese patients, two different kinds of follow-up after discharge from in-hospital rehabilitation programme. The main questions addressed are: - primary outcome: comparing the dropout rate at month 11 of patients followed-up by a telemedicine methodology with that of a traditional outpatient visit follow-up. - secondary outcome: comparing the amount of weight loss at month 11 in patients followed-up by telemedicine with that registered in patients followed-up by traditional outpatient visits. Participants are given a set of instruments (scale, activity tracker, automatic blood pressure monitor, oxymeter, and glucometer) and asked to measure vital parameters following a predetermined schedule for one year. Subjects are asked to engage in regular physical activity and follow the nutritional guidelines received at the moment of discharge from hospital.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 15, 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI 38-60 kg/m2,
• age between 18 and 65 years,
• patient residing in Piedmont, Lombardy
• Recent admission to San Giuseppe Hospital in Piancavallo for a period of residential rehabilitation.
• Patient with wi-fi and/or mobile data connection at home.

Exclusion Criteria:

• illiteracy
• inability to engage in physical activity
• psychiatric illnesses capable of impairing the proper use of the devices provided by telemonitoring
• cognitive impairment, mental retardation
• predictability of long periods of stay abroad
• anticipation or planning of pregnancy during the year following discharge
• legal protection

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid
• Severe Obesity

Intervention

Device:
• Telemonitoring
Monitoring of the required parameters by means of the data provided by the devices used by patients. The data (weight, body composition, blood pressure, oxygen saturation, physical activity, heart rate and blood glucose) collected according to the predetermined schedule are then saved in a cloud accessible to researchers.

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano	Oggebbio	VCO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	changes in blood pressure registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.	Variation in blood pressure between the time of discharge and 11 months in patients undergoing the two different strategies in studies	12 months
Other	changes in heart rate registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.	Variation in heart rate between the time of discharge and 11 months in patients undergoing the two different strategies in studies	12 months
Other	changes in oxygen saturation registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.	Variation in oxygen saturation between the time of discharge and 11 months in patients undergoing the two different strategies in studies	12 months
Other	changes in blood glucose registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.	Variation in blood glucose between the time of discharge and 11 months in patients undergoing the two different strategies in studies	12 months
Primary	+ dropout rate at month 11 of patients followed-up by a telemedicine methodology with that of a traditional outpatient visit follow-up.	Percentage of patients still in care at month 11 after discharge in each of the two subgroups.	12 months
Secondary	amount of weight loss at month 11 in patients followed-up by telemedicine with that registered in patients followed-up by traditional outpatient visits.	Percentage of patients with weight loss of at least 5% and percentage of patients with weight loss between 0% and 5% at month 11 in each of the two subgroups.	12 months