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NCT04041193: SIDERA^B

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

Status unknown NA Last updated 17 June 2020
What this trial tests

NA trial testing SIDERA^B in Parkinson Disease (PD) in 150 participants. Status unknown.

Timeline
29 July 2019
Primary endpoint
15 October 2020
1 January 2021

Quick facts

Lead sponsorFondazione Don Carlo Gnocchi Onlus
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment150
Start date29 July 2019
Primary completion15 October 2020
Estimated completion1 January 2021
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Fondazione Don Carlo Gnocchi Onlus — full company profile →

Who can join

Adults 18 to 85, any sex, with Parkinson Disease (PD) or Chronic Heart Failure (CHF). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. System Integrated Digital Empowerment and Rehabilitation to promote patient Activation and well-Being (SIDERA^B): Protocol for a Randomized Crossover Trial on Effectiveness and Implementation
    Rossetto F, Borgnis F, Blasi V, Banfi PI, et al · · 2022 · DOI 10.1101/2022.04.19.22274012

Verify or expand the search:

Other recruiting trials for Parkinson Disease (PD)

Currently open trials in the same condition.

Other Fondazione Don Carlo Gnocchi Onlus trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04041193.

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