Telemonitoring System for Early Diagnosis of COPD Exacerbations.
1 other identifier
interventional
500
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2018
CompletedFirst Posted
Study publicly available on registry
November 14, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedFebruary 20, 2020
February 1, 2020
3 years
November 5, 2018
February 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants needing ER or hospital admission for bronchial exacerbation
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.
One year
Study Arms (1)
BPCO Media Kit
EXPERIMENTALThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with COPD with two or more exacerbations every year or at least one leading to hospitalization.
You may not qualify if:
- long-term oxygen therapy
- cognitive impairment
- a life expectancy limited to one year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laboratori di Informatica Applicatalead
- Campus Bio-Medico Universitycollaborator
Study Sites (3)
ASSL Cagliari - Pneumologia Territoriale di Cagliari Area Vasta
Cagliari, Sardinia, Italy
ASSL Lanusei - Distretto di Tortolì
Lanusei, Sardinia, Italy
ASSL Nuoro - Distretto di Nuoro
Nuoro, Sardinia, Italy
Related Publications (1)
Merone M, Pedone C, Capasso G, Incalzi RA, Soda P. A Decision Support System for Tele-Monitoring COPD-Related Worrisome Events. IEEE J Biomed Health Inform. 2017 Mar;21(2):296-302. doi: 10.1109/JBHI.2017.2654682. Epub 2017 Jan 17.
PMID: 28103562BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raffaele Antonelli Incalzi, MD
Campus BioMedico
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2018
First Posted
November 14, 2018
Study Start
January 1, 2019
Primary Completion
January 1, 2022
Study Completion
January 1, 2022
Last Updated
February 20, 2020
Record last verified: 2020-02