Clinical trial NCT04041193: An Innovative Disease-net Management Model for Non-communicable Diseases (SIDERA^B)
Official title: An Innovative Disease-net Management Model for Non-communicable Diseases: a System for Integrated Home-care and Assisted Rehabilitation for Wellbeing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease (PD)
Chronic Heart Failure (CHF)
Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Università Carlo Cattaneo , Castellanza
name: University of Milano Bicocca
First posted: 2019-08-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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), 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 criteria: 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

   1. PD diagnosis according to the MDS criteria (Postuma et al., 2015)
   2. staging between 1.5 and 3 on the Hoehn \& Yahr scale (Goetz et al., 2004)
7. age between 18 and 85 years.

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).

Primary outcomes:
measure: Change in Activation of Patients as measured by Patient Activation Measure 13 (PAM13) scale
timeFrame: Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)
measure: Change in activity and participation as measured by the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)
Secondary outcomes:
measure: Change in patient's self-rated health as measured by EuroQol five dimensions (5D) and five levels (5L)
timeFrame: Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)
measure: Change in health status scores as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ; Green et al., 2000; ad. it.: Miani et al., 2003) only in patients with Chronic Heart Failure
timeFrame: Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)
measure: Change in health-related quality of life as measured by Parkinsons' Disease (PD) Questionnaire (PDQ) only in PD patients
timeFrame: Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)
measure: Change in health status scores as measured by St George's Respiratory Questionnaire (SGRQ) only in patients with COPD.
timeFrame: Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)
measure: Change in care-relationship as Measured by Mutuality Scale (MS)
timeFrame: Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)
measure: Changes in scores of environmental mastery as measured by Psychological well-being scale (PWB)
timeFrame: Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)
measure: Change in Dispositional Optimism as measured by Life Orientation Test-Revised (LOT-R).
timeFrame: Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)
measure: Change in resilience as measured by Connor-Davidson ResIlience SCale (CD-RISC 10-item version).
timeFrame: Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)
measure: Changes in affect as measured by Positive-Negative Affect Schedule (PANAS)
timeFrame: Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)
measure: Maintenance or improvement of Aerobic Capacity and Gait using 6' Minute Walking Test (6MWT)
timeFrame: Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)
measure: Changes in Balance, Functional Mobility and Strength measured by 30 Second Sit to Stand Test only CHF
timeFrame: Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)
measure: Change in motor functionality as measured by Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part-III only in Parkinson's Disease group
timeFrame: Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)
measure: Change in executive functions as measured by Picture Interpretation test 360 (PIT360) only in Parkinson's disease group.
timeFrame: Baseline, post treatment (up to 3 or 4 months)
measure: Change in general cognitive function as measured by the Montreal Cognitive Assessment (MoCA) test only in Parkinson's disease group.
timeFrame: Baseline, post treatment (up to 3 or 4 months)
measure: Maintaining cardiovascular performance as measured by echocardiography
timeFrame: Baseline, post treatment (up to 3 or 4 months)
measure: Maintaining the Forced expiratory volume in the 1st second (FEV1%) as measured by spirometry (only in COPD patients)
timeFrame: Baseline, post treatment (up to 3 or 4 months)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione Don Carlo Gnocchi ONLUS
Study officials:
affiliation: Fondazione Don Carlo Gnocchi Onlus
name: Francesca Baglio, MD
role: PRINCIPAL_INVESTIGATOR
References: