NCT05786092

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2020

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

4 years

First QC Date

March 15, 2023

Last Update Submit

March 15, 2023

Conditions

Severe Obesity

Outcome Measures

Primary Outcomes (1)

  • + 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 Outcomes (1)

  • amount of weight loss at month 11 in patients followed-up by telemedicine with that registered in patients followed-up by traditional outpatient visits.

    12 months

Other Outcomes (4)

  • changes in blood pressure registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.

    12 months

  • changes in heart rate registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.

    12 months

  • changes in oxygen saturation registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.

    12 months

  • +1 more other outcomes

Study Arms (2)

treatment

EXPERIMENTAL
Device: Telemonitoring

control

NO INTERVENTION

Interventions

TelemonitoringDEVICE

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.

treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano

Oggebbio, VCO, 28824, Italy

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Massimo Scacchi

CONTACT

+390323514301massimo.scacchi@unimi.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 27, 2023

Study Start

September 15, 2020

Primary Completion

September 1, 2024

Study Completion

October 15, 2024

Last Updated

March 27, 2023

Record last verified: 2023-03

Locations

IT(1)