Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06331416
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-03-19
Brief Title:
Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation
Sponsor:
University of Trieste
Organization:
University of Trieste
Study Overview
Official Title:
Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic obstructive pulmonary disease COPD exacerbations are risk factors for disease progression and short-term re- hospitalizations We propose a randomized controlled trial to evaluate the efficacy of a one-device multiparameter telemonitoring in reducing functional decline symptoms and risk of re-hospitalization of patients discharged after hospitalization for exacerbated COPD
Detailed Description:
Respiratory diseases such as asthma chronic obstructive pulmonary disease COPD lung cancer obstructive sleep apnea syndrome pulmonary fibrosis and others are important causes of morbidity and mortality and have a substantial impact on healthcare costs Furthermore the Coronavirus-19 COVID-19 pandemic has shown how respiratory complications are the most dangerous for infected subjects as they can evolve into a severe pneumonia burdened by either subacute or chronic complications Strict monitoring early treatment initiation and timely hospitalization are fundamental to ameliorate short-term prognosis and reduce long-term sequelae of all acute respiratory conditions including chronic obstructive pulmonary disease COPD Indeed acute worsening of respiratory symptoms called exacerbations often occur during the course of the disease COPD exacerbations are associated with an accelerated decline in respiratory function and exacerbation frequency or intensity is a powerful predictor of future episodes and ultimate mortality which reaches as high as 50 at 5 years Indeed exacerbation frequency is the strongest single factor related to future exacerbations and mortality rates increase 3-fold as exacerbation frequency increases from 0 to 3 or more per year Recent data shown that 30-day readmission rate for COPD patients after discharge ranged from 226 to 24 while 90-day readmission was 351 to 43 in different studies Furthermore severe COPD exacerbations resulting in hospitalization can be up to 60 times more expensive than mild or moderate exacerbations managed by primary care services As a consequence the medical community have launched numerous initiatives to reduce exacerbations with a particular focus on reducing readmissions These initiatives involve improving medication regimens and adherence smoking cessation pulmonary rehabilitation assessments for oxygen supplementation and noninvasive ventilation and close follow-up by clinicians following discharge At the current state of things patients discharged after an hospitalization for COPD exacerbation are followed-up through discrete in-person evaluation within one to three months However this timeframe is often not sufficient to identify clinical deterioration and the need for changes in the therapeutic strategy eg switch of inhaler counselling on the inhalation technique need for oral add-on therapy to avoid recurrence of symptoms and re-hospitalization Nevertheless there are no established programs to help medical doctors reduce COPD re-admissions Since over two decades telemedicine has been demonstrated effective in improving patients health-related quality of life and in increasing the efficiency of care processes but it has only recently been proposed as a strategy to reduce COPD readmission rate Indeed The COVID-19 pandemic has increased the awareness on the available systems for telemonitoring and favored the development of new ones Telemonitoring is one major field of telemedicine which encompasses remote tracking of physiological parameters either in real time or using store-and-forward technologies allowing to screen for the patients who could benefit most of either home visits or hospitalization Multiple devices have been made available for these purposes during the COVID-19 pandemic We designed a randomized controlled trial to evaluate the ability of telemonitoring to avoid lung function decline reduce symptoms and the risk of re-hospitalizations of patients discharged after a COPD exacerbation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None