Clinical trial NCT05786092: Impact of Telemonitoring on Metabolic Variables in Severe Obesity
Official title: The Role of Home Telemonitoring in the Evaluation of Patients With Severe Obesity After a Period of Residential Metabolic Rehabilitation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Obesity
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: + dropout rate at month 11 of patients followed-up by a telemedicine methodology with that of a traditional outpatient visit follow-up.
timeFrame: 12 months
Secondary outcomes:
measure: amount of weight loss at month 11 in patients followed-up by telemedicine with that registered in patients followed-up by traditional outpatient visits.
timeFrame: 12 months
Other outcomes:
measure: changes in blood pressure registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.
timeFrame: 12 months
measure: changes in heart rate registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.
timeFrame: 12 months
measure: changes in oxygen saturation registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.
timeFrame: 12 months
measure: changes in blood glucose registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.
timeFrame: 12 months
Locations:
city: Oggebbio
country: Italy
facility: Istituto Auxologico Italiano
state: VCO
Study officials:
References: