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An Innovative Disease-net Management Model for Non-communicable Diseases (SIDERA^B) | Clinical Trials | Clareo Health

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An Innovative Disease-net Management Model for Non-communicable Diseases (SIDERA^B)

An Innovative Disease-net Management Model for Non-communicable Diseases: a System for Integrated Home-care and Assisted Rehabilitation for Wellbeing

NCT04041193•Fondazione Don Carlo Gnocchi Onlus

View on ClinicalTrials.gov

Summary

The SIDERA\^B telerehabilitation system is enabled by a multi-domain, multi-device platform providing at home multi-component rehabilitation, targeting cardiovascular (Chronic Heart Failure, CHF), pulmonary (Chronic Obstructive Pulmonary Disease, COPD) and neurodegenerative (Parkinson Disease, PD) chronic diseases. The rehabilitation program embeds engagement activities for patient and caregiver, to empower appropriation of the SIDERA\^B care routines and fuel their well-being resources. The multidisciplinary layering of SIDERA\^B is reflected in the validation protocol including a) clinical and well-being evaluation through a cross-over study confronting usual care with the SIDERA\^B activities; b) technological evaluation: Health Technology Assessment for organizational, legal and equity impacts; c) economic evaluation: process mapping and budget impact analysis to define a sustainable reimbursement process for the innovative telerehabilitation pathway.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. agreement to participate, with the signature of the informed consent form.
•2. availability of a caregiver/study partner, who agrees to support the participant through the SIDERA\^B program.
•3. living in one's own home.
•4. clinical diagnosis of Chronic Heart Failure (CHF) and
•1. functional New York Heart Association (NYHA) class II and III with an Ejection Fraction (EF) ≤ 40%
•2. etiology of CHF primitive or post-ischemic.
•5. clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD) and
•1. COPD diagnosis according to the American Thoracic Society (ATS) and the European Respiratory Society (ERS) criteria with FEV1/FVC ratio \<70%
•2. presence of airway limitation according to ATS/ERS and GOLD criteria.
•6. clinical diagnosis of Parkinson Disease (PD) and
+3 more criteria

Exclusion Criteria

•1. presence of comorbidities that may prevent you from undertaking a secure home program or determining clinical instability (i.e. severe orthopedic or severe cognitive deficits).
•2. presence of risk conditions for safety under strain in patients with CHF (i.e. severe symptomatic aortic stenosis, evidence of ischemia due to minimal/low-intensity efforts).
•3. COPD patients who do not need rehabilitation treatment (GOLD 1 / A class) or with severe COPD (GOLD 4 / D class)
•4. COPD patients with overlap with other respiratory diseases or not in treatment or in the absence of good ventilatory compensation in the last 6 months
•5. COPD with global respiratory failure with PaCO2\> 55 mmHg
•6. PD patients with other neurological pathologies or with severe psychiatric complications
•7. pathological score to a screening test for cognitive impairment (Montreal Cognitive Assessment test - MoCA test \<17.54; Conti et al., 2015).

Locations (1)

Fondazione Don Carlo Gnocchi ONLUS

Milan, Italy

Key Dates

Start Date

July 29, 2019

Primary Completion Date

October 15, 2020

Completion Date

January 1, 2021

Last Updated

June 17, 2020

Enrollment

150

ESTIMATED participants

Conditions

Parkinson Disease (PD)Chronic Heart Failure (CHF)Chronic Obstructive Pulmonary Disease (COPD)

Interventions

SIDERA^B

BEHAVIORAL

Usual Care Program

BEHAVIORAL

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGNA

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

NCT07382258

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGNA

Mindful-Breath for People With COPD

NCT07195838

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 17, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Innovative Disease-net Management Model for Non-communicable Diseases (SIDERA^B)

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

Mindful-Breath for People With COPD

The HELlenic Thoracic Society Initiative for CΟPD and CVD

Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease

Magnetic Stimulation of Diaphragm in Chronic Obstructive Pulmonary Disease