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

NCT04041193 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-06-17

No results posted yet for this study

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)

Interventions

BEHAVIORAL

SIDERA^B

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)

BEHAVIORAL

Usual Care Program

Usual Care program activities (paper and pencil at home)

Sponsors & Collaborators

  • Università Carlo Cattaneo , Castellanza

    collaborator UNKNOWN

  • University of Milano Bicocca

    collaborator OTHER

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Principal Investigators

  • Francesca Baglio, MD · Fondazione Don Carlo Gnocchi Onlus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-29
Primary Completion
2020-10-15
Completion
2021-01-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04041193 on ClinicalTrials.gov