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Telemonitoring System for Early Diagnosis of COPD Exacerbations.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03739957
Recruitment Status : Unknown
Verified February 2020 by Laboratori di Informatica Applicata.
Recruitment status was:  Recruiting
First Posted : November 14, 2018
Last Update Posted : February 20, 2020
Campus Bio-Medico University
Information provided by (Responsible Party):
Laboratori di Informatica Applicata

Brief Summary:
A tailored management of COPD patients would obviously allow to reduce costs for hospitalizations and improve quality of life. This management could benefit of the Information and Comunication Technology support, which can offer the possibility of telemonitoring patients without the need of repeated hospital visits and improving the efficacy of healthcare services. Moreover, the high frequency of exacerbations and their often atypical clinical presentation in the aged patient make particularly desirable the availability of a telemonitoring system which could guarantee continuous control and early intervention in case of necessity. The aim of the present study is to test an innovative telemonitoring system in patients with COPD.

Condition or disease Intervention/treatment Phase
COPD Exacerbation COPD Device: BPCO Media Kit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Telemonitoring System for Early Diagnosis of COPD Exacerbations.
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BPCO Media Kit
The kit is composed of a Bluetooth pulse oximeter and an APP for Android system downloadable from Google Play and installed on the Android smartphone of the patient from version 4.1 on.
Device: BPCO Media Kit
Telemonitoring system for patients with COPD

Primary Outcome Measures :
  1. Number of participants needing ER or hospital admission for bronchial exacerbation [ Time Frame: One year ]
    The cause of ER or hospital admission will be referred to bronchial exacerbation if any change occurred in respiratory health that requires a change in drug therapy.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with COPD with two or more exacerbations every year or at least one leading to hospitalization.

Exclusion Criteria:

  • long-term oxygen therapy
  • cognitive impairment
  • a life expectancy limited to one year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03739957

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Contact: Antonio De Vincentis, MD 003906225411

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ASSL Cagliari - Pneumologia Territoriale di Cagliari Area Vasta Recruiting
Cagliari, Sardegna, Italy
Contact: Cesare Severino         
Principal Investigator: Cesare Severino         
ASSL Lanusei - Distretto di Tortolì Recruiting
Lanusei, Sardegna, Italy
Contact: Sandro Rubiu         
Principal Investigator: Sandro Rubiu         
Principal Investigator: Angela Maria Bussu         
ASSL Nuoro - Distretto di Nuoro Recruiting
Nuoro, Sardegna, Italy
Contact: Gesuina Cherchi         
Principal Investigator: Gesuina Cherchi         
Principal Investigator: Gianfranca Piredda         
Sponsors and Collaborators
Laboratori di Informatica Applicata
Campus Bio-Medico University
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Principal Investigator: Raffaele Antonelli Incalzi, MD Campus BioMedico
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Responsible Party: Laboratori di Informatica Applicata Identifier: NCT03739957    
Other Study ID Numbers: 10/2018/CE
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laboratori di Informatica Applicata:
Telemonitoring systems
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases