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

NCT04041193 | Unknown DMC

• 1 other identifier: FdG_SIDERAb_01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Change in Activation of Patients as measured by Patient Activation Measure 13 (PAM13) scale

  Patient Activation Measure 13 (PAM13) is a 13-item scale that assesses a person's underlying knowledge, skills and confidence integral to managing his or her health and healthcare. PAM13 total score ranging from 0 to 100. Higher values represent a better outcome. Specifically, individuals in the lowest activation level do not yet understand the importance of their role in managing their health and have significant knowledge gaps and limited self-management skills. Individuals in the highest activation level are proactive with their health, have developed strong self- management skills, and are resilient in times of stress or change.

  Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)

• Change in activity and participation as measured by the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)

  WHODAS 2.0 covers six domains of functioning including Cognition, Mobility, Self-care, Getting along, Life activities, Participation. Scores assigned to each item are on a 5-point scale ranging from (0) "none" to (4) "extreme" with higher scores indicating a higher disability. The 36-item version will be administered and both summary scores (score range 0-144 with higher numbers indicating higher disability) and domain-specific scores for the six different functioning domains (score range 0-24 for each domain with higher numbers indicating higher disability) will be considered.

  Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)

Secondary Outcomes (16)

• Change in patient's self-rated health as measured by EuroQol five dimensions (5D) and five levels (5L)

  Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)

• 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

  Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)

• Change in health-related quality of life as measured by Parkinsons' Disease (PD) Questionnaire (PDQ) only in PD patients

  Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)

• Change in health status scores as measured by St George's Respiratory Questionnaire (SGRQ) only in patients with COPD.

  Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)

• Change in care-relationship as Measured by Mutuality Scale (MS)

  Baseline, post treatment (up to 3 or 4 months) and follow-up (up to 3 or 4 months)

Study Arms (2)

SIDERA^B

EXPERIMENTAL

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.

Behavioral: SIDERA^B

usual care

ACTIVE COMPARATOR

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.

Behavioral: Usual Care Program

Interventions

SIDERA^B BEHAVIORAL

The group will receive a kit home-based (a tablet home, access to a daily individualized training program). Five sessions for a week (3 components: monitoring, motor rehabilitation acitivities, motivational support)

SIDERA^B

Usual Care Program BEHAVIORAL

Usual Care program activities (paper and pencil at home)

usual care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Università Carlo Cattaneo , Castellanza: collaborator
• University of Milano Bicocca: collaborator

Study Sites (1)

Fondazione Don Carlo Gnocchi ONLUS

Milan, 20148, Italy

Location

MeSH Terms

Conditions

Parkinson Disease; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesca Baglio, MD

  Fondazione Don Carlo Gnocchi Onlus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: August 1, 2019
• Study Start: July 29, 2019
• Primary Completion: October 15, 2020
• Study Completion: January 1, 2021
• Last Updated: June 17, 2020

Record last verified: 2019-06

Locations

IT (1)