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

NCT05955482 | Active Not Recruiting

• 1 other identifier: 50M16FSHP
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Comorbidities and Coexisting Conditions

Outcome Measures

Primary Outcomes (1)

• Moderate & Severe Exacerbations

  Rate of moderate and severe exacerbations of COPD, measured by the health insurer or provider's records.

  12 months

Secondary Outcomes (3)

• Readmissions

  30 days post admission

• Hospital days

  12 months

• Cost of care

  12 months

Study Arms (2)

NuvoAir Clinical service

Patients with COPD receiving usual care plus NuvoAir clinical services.

Other: NuvoAir Clinical Service

Standard Care

Propensity matched controls with COPD who receive usual care.

Interventions

NuvoAir Clinical Service 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.

NuvoAir Clinical service

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A propensity matched comparison group will be selected from the same insured population (Security Health Plan of Wisconsin): Patients with COPD of comparable COPD severity, age, gender from the same region and type of health insurance (Medicare Advantage).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NuvoAir Medical PC: lead

Study Sites (1)

Marshfield Clinic Research Institute

Marshfield, Wisconsin, 54449, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey VanWormer, PHD

  Marshfield Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 21, 2023
• Study Start: July 24, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)