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

Don Carlo Gnocchi Onlus Foundation

Status: Unknown

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

Treatments: Behavioral: Usual Care Program; Behavioral: SIDERA^B

Study type: Interventional

Funder types: Other

Identifiers

NCT04041193

FdG_SIDERAb_01

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

   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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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150 participants in 2 patient groups

SIDERA^B

Experimental group

Description:

Behavioral: telerehabilitation activities Participants will receive 3months (Chronic Heart Failure) or 4 months (Chronic Obstructive Pulmonary Disease and Parkinson Disease) 5 sessions/week of an individualized telerehabilitation program at home. The sessions will initially be tailored to the patient's baseline characteristics. The exercise program will be charged by the therapist weekly. Each patient's performed session will be reviewed by the therapist.

Treatment:

Behavioral: SIDERA^B

usual care

Active Comparator group

Description:

Behavioral: paper and pencil activities as usual rehabilitation at home Participants will receive 3months (Chronic Heart Failure) or 4 months (Chronic Obstructive Pulmonary Disease and Parkinson Disease) of a usual rehabilitation program.

Treatment:

Behavioral: Usual Care Program