Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05955482
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-07-13
Brief Title:
Pragmatic Assessment of the NuvoAir Clinical Service in the Management of Patients With Chronic Obstructive Pulmonary Disease
Sponsor:
NuvoAir Medical PC
Organization:
NuvoAir Medical PC
Study Overview
Official Title:
PROMISE Pragmatic Assessment of the NuvoAir Clinical Service in the Management of Patients With Chronic Obstructive Pulmonary Disease
Status:
RECRUITING
Status Verified Date:
2023-12
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:
PROMISE
Brief Summary:
This is a 12 month study of up to 500 people with COPD to determine if the NuvoAir clinical service leads to lower rates of severe COPD exacerbations hospitalizations emergency room visits and total cost of care compared to a similar group that doesnt receive care from the NuvoAir clinical service
Detailed Description:
Description The program will be a virtual decentralized pragmatic evaluation of an implementation of the NuvoAir Clinical service for patients with COPD residing in the United States of America and who are enrolled with one or more health insurers or providers supporting the program The evaluation will be organized around two cohorts Patients with an ICD10 code for COPD in the health insurers or providers database
Who use the NuvoAir Clinical service vs those
Who undergo standard care matched control - no intervention
Each patient in the NuvoAir cohort will receive their routine clinical care from their primary care provider with the addition of the NuvoAir Clinical service The NuvoAir Clinical service offers comprehensive monitoring of health parameters and patient-reported outcomes as well as personalized clinical and behavioral interventions tailored to the patients unique needs and their clinical risk Furthermore it involves virtual interaction with a NuvoAir Coach who provides guidance and assistance in navigating and utilizing the service A dedicated NuvoAir care coordinator is available to offer self-management support and educational resources aiming to enhance the management of COPD and other comorbidities In situations where patients encounter new or worsening symptoms the NuvoAir clinical team is accessible to provide medical intervention advice and triage as required
Each patient in the standard care cohorts will receive their routine clinical care from their healthcare provider as usual Only anonymized data that is usually collected by their health insurer or provider will be subject to analysis no additional data will be collected for the standard care cohort
NuvoAir and standard care cohorts will be matched on the basis of age gender disease severity ICD10 code for COPD with a severe exacerbation of COPD in the previous 12 months geographic place and period of entry into the program The program period will include 1 year of active participation for NuvoAir users followed by 1 year of follow-up using health insurer or provider records
Objectives To determine if use of the NuvoAir clinical service results in a lower rate and number of moderate and severe exacerbations of COPD lower readmissions due to COPD exacerbation within a 30-day period following a COPD exacerbation lower days in hospital and lower healthcare costs compared with the matched cohorts of standard care patients who do not use the NuvoAir clinical service To determine if use of the NuvoAir results in reduced readmissions due to COPD during the 30-day period following an exacerbation improved health status and improved adherence compared with prior to the programbaseline
Who use the NuvoAir Clinical service vs those
Who undergo standard care matched control - no intervention
Each patient in the NuvoAir cohort will receive their routine clinical care from their primary care provider with the addition of the NuvoAir Clinical service The NuvoAir Clinical service offers comprehensive monitoring of health parameters and patient-reported outcomes as well as personalized clinical and behavioral interventions tailored to the patients unique needs and their clinical risk Furthermore it involves virtual interaction with a NuvoAir Coach who provides guidance and assistance in navigating and utilizing the service A dedicated NuvoAir care coordinator is available to offer self-management support and educational resources aiming to enhance the management of COPD and other comorbidities In situations where patients encounter new or worsening symptoms the NuvoAir clinical team is accessible to provide medical intervention advice and triage as required
Each patient in the standard care cohorts will receive their routine clinical care from their healthcare provider as usual Only anonymized data that is usually collected by their health insurer or provider will be subject to analysis no additional data will be collected for the standard care cohort
NuvoAir and standard care cohorts will be matched on the basis of age gender disease severity ICD10 code for COPD with a severe exacerbation of COPD in the previous 12 months geographic place and period of entry into the program The program period will include 1 year of active participation for NuvoAir users followed by 1 year of follow-up using health insurer or provider records
Objectives To determine if use of the NuvoAir clinical service results in a lower rate and number of moderate and severe exacerbations of COPD lower readmissions due to COPD exacerbation within a 30-day period following a COPD exacerbation lower days in hospital and lower healthcare costs compared with the matched cohorts of standard care patients who do not use the NuvoAir clinical service To determine if use of the NuvoAir results in reduced readmissions due to COPD during the 30-day period following an exacerbation improved health status and improved adherence compared with prior to the programbaseline
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