Pragmatic Assessment of the NuvoAir Clinical Service in the Management of Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT05955482

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-24
• Study Completion Date: 2025-07-31

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 doesn't 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 insurer's or provider's 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 program/baseline.

Conditions

COPD; Comorbidities and Coexisting Conditions

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

NuvoAir Clinical service

Patients with COPD receiving usual care plus NuvoAir clinical services.

NuvoAir Clinical Service

Intervention Type: OTHER

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.

Standard Care

Propensity matched controls with COPD who receive usual care.

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Have COPD, including emphysema and chronic bronchitis, per relevant COPD diagnostic codes in the past 2 years

• Are age ≥30 years
• Have access to a smartphone, cell phone, or landline telephone

Exclusion Criteria

Do not have serious medical illness that would interfere with cooperation or understanding of instructions, including terminal illness, active substance abuse, or unstable mental illness or psychiatric condition

• Does not have severe uncompensated heart failure, acute cor pulmonale, clinically unstable pulmonary embolism, history of syncope related to forced expiration/cough, cerebral aneurysm, presence of pneumothorax.
• Is not pregnant or known intention to become pregnant within 12 months

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NuvoAir Medical PC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey VanWormer, PHD

Role: PRINCIPAL_INVESTIGATOR

Marshfield Clinic

Locations

Marshfield Clinic Research Institute

Marshfield, Wisconsin, United States

Countries

United States

Other Identifiers

50M16FSHP

Identifier Type: -

Identifier Source: org_study_id