Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379529
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2023-08-25
Brief Title:
The COPD CARE Study Evaluating the Impact of a Virtual-First COPD Service on Major Cardiac and Respiratory Events
Sponsor:
NuvoAir Medical PC
Organization:
NuvoAir Medical PC
Study Overview
Official Title:
The COPD CARE Study Evaluating the Impact of a Virtual-First COPD Service on Major Cardiac and Respiratory Events
Status:
NOT_YET_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:
A 12 month interventional study of up to 1050 people with COPD to determine if the NuvoAir virtual-first clinical service leads to fewer moderate and severe COPD exacerbations and cardiac events reduces healthcare utilization and lowers the total cost of care compared to a control cohort that receives standard care only
Detailed Description:
A virtual decentralized pragmatic prospective matched cohort study conducted in patients with COPD residing in the United States of America who are enrolled with one or more health insurers or providers supporting the study The study aims to evaluate COPD outcomes with the addition of the NuvoAir virtual-first clinical service compared to a cohort receiving standard care matched control - no intervention
Each patient in the NuvoAir cohort will receive routine clinical care from their providers 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 clinical risk The service involves virtual interaction with NuvoAir coaches who provide guidance and assistance in navigating and utilizing the service Dedicated NuvoAir care coordinators are available to offer self-management support and educational resources aiming to enhance the management of COPD and comorbidities such as cardiovascular conditions In situations where patients encounter new or worsening symptoms the NuvoAir clinical team is accessible to provide advice and triage as required
Each patient in the standard care cohort will receive their routine clinical care from their healthcare provider Only de-identified 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 or disease severity score of 2 or 3 as defined by their health plan and period of entry into the study Eligible patients will be recruited from Medicare patients in Medicare Advantage plans that are administered by the private health insurance company or health care provider supporting the study
Key Objectives To determine if use of the NuvoAir clinical service results in a reduction in the rate and number of moderate and severe exacerbations of COPD major cardiac events hospitalizations and 30-day readmissions days hospitalized and lowers healthcare costs compared with the matched cohort of patients receiving standard care only
Study duration The overall study duration is expected to be two years with one year of active patient participation using the NuvoAir clinical service following the end of the baseline period This will be followed by one year of follow-up by reference to health insurer or providers records
Enrollment The study will enroll up to 350 patients for the NuvoAir intervention and 700 for the standard care cohort for a total of 1050 patients
Each patient in the NuvoAir cohort will receive routine clinical care from their providers 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 clinical risk The service involves virtual interaction with NuvoAir coaches who provide guidance and assistance in navigating and utilizing the service Dedicated NuvoAir care coordinators are available to offer self-management support and educational resources aiming to enhance the management of COPD and comorbidities such as cardiovascular conditions In situations where patients encounter new or worsening symptoms the NuvoAir clinical team is accessible to provide advice and triage as required
Each patient in the standard care cohort will receive their routine clinical care from their healthcare provider Only de-identified 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 or disease severity score of 2 or 3 as defined by their health plan and period of entry into the study Eligible patients will be recruited from Medicare patients in Medicare Advantage plans that are administered by the private health insurance company or health care provider supporting the study
Key Objectives To determine if use of the NuvoAir clinical service results in a reduction in the rate and number of moderate and severe exacerbations of COPD major cardiac events hospitalizations and 30-day readmissions days hospitalized and lowers healthcare costs compared with the matched cohort of patients receiving standard care only
Study duration The overall study duration is expected to be two years with one year of active patient participation using the NuvoAir clinical service following the end of the baseline period This will be followed by one year of follow-up by reference to health insurer or providers records
Enrollment The study will enroll up to 350 patients for the NuvoAir intervention and 700 for the standard care cohort for a total of 1050 patients
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