Status:
UNKNOWN
An Innovative Disease-net Management Model for Non-communicable Diseases (SIDERA^B)
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Collaborating Sponsors:
Università Carlo Cattaneo , Castellanza
University of Milano Bicocca
Conditions:
Parkinson Disease (PD)
Chronic Heart Failure (CHF)
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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), pul...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- agreement to participate, with the signature of the informed consent form.
- availability of a caregiver/study partner, who agrees to support the participant through the SIDERA\^B program.
- living in one's own home.
- clinical diagnosis of Chronic Heart Failure (CHF) and
- functional New York Heart Association (NYHA) class II and III with an Ejection Fraction (EF) ≤ 40%
- etiology of CHF primitive or post-ischemic.
- clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD) and
- COPD diagnosis according to the American Thoracic Society (ATS) and the European Respiratory Society (ERS) criteria with FEV1/FVC ratio \<70%
- presence of airway limitation according to ATS/ERS and GOLD criteria.
- clinical diagnosis of Parkinson Disease (PD) and
- PD diagnosis according to the MDS criteria (Postuma et al., 2015)
- staging between 1.5 and 3 on the Hoehn \& Yahr scale (Goetz et al., 2004)
- age between 18 and 85 years.
- Exclusion Criteria:
- 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).
- 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).
- COPD patients who do not need rehabilitation treatment (GOLD 1 / A class) or with severe COPD (GOLD 4 / D class)
- 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
- COPD with global respiratory failure with PaCO2\> 55 mmHg
- PD patients with other neurological pathologies or with severe psychiatric complications
- pathological score to a screening test for cognitive impairment (Montreal Cognitive Assessment test - MoCA test \<17.54; Conti et al., 2015).
Exclusion
Key Trial Info
Start Date :
July 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04041193
Start Date
July 29 2019
End Date
January 1 2021
Last Update
June 17 2020
Active Locations (1)
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1
Fondazione Don Carlo Gnocchi ONLUS
Milan, Italy, 20148