The COPD CARE Study: Evaluating the Impact of a Virtual-First COPD Service on Major Cardiac and Respiratory Events

NCT06379529 | Not Yet Recruiting DMC

• 1 other identifier: USCOPD2022B
• Study Type: interventional
• Target: 1,050
• Locations: 0 countries
• Sites: N/A

Brief Summary

A 12 month interventional study of up to 1,050 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.

Conditions

COPD Exacerbation; COPD; Cardio/Pulm: Heart Failure

Keywords

COPD; COPD Exacerbation; COPD Hospitalization; COPD Readmission; COPD Costs; Medicare; Medicare Advantage

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 (9)

• Severe COPD Exacerbations

  12 months

• Major Adverse Cardiac Event

  12 months

• 30-Day COPD Related Readmissions

  12 months

• All-Cause Hospitalizations

  12 months

• All-Cause Readmissions

  12 months

Other Outcomes (7)

• Short-Acting Beta-Agonists Used

  12 months

• Courses of Oral Antibiotics/Steroids

  12 months

• Self-efficacy

  12 months

Study Arms (2)

NuvoAir clinical service

EXPERIMENTAL

Patients with COPD receiving usual care plus the NuvoAir clinical service.The NuvoAir clinical service offers comprehensive remote 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 for self-management support and educational resources, aiming to enhance the management of COPD and other comorbidities including cardiovascular conditions. In situations where patients encounter new or worsening symptoms, the NuvoAir clinical team is accessible to advise and triage as required.

Other: NuvoAir clinical service

Standard Care

NO INTERVENTION

Propensity matched controls with COPD who receive usual care.

Interventions

NuvoAir clinical service OTHER

Patients with COPD receiving usual care plus NuvoAir clinical services.

NuvoAir clinical service

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Twelve months of claims data in the health insurer or provider's database for baseline
• ICD10 code for COPD (including emphysema and chronic bronchitis) with a severe exacerbation of COPD in the previous 12 months (defined as ER visit or hospitalization related to COPD or severity score of 2 or 3)
• Cooperative, i.e., subject should be able to follow and understand instructions
• Access to a phone (smartphone, cell phone, or landline)
• Willingness to sign a medical release form for treating healthcare facilities

You may not qualify if:

• Does not have access to a a phone (smartphone, cell phone, or landline)
• Lack of cooperation, subject cannot follow and understand instructions
• Other serious medical illness that, in the opinion of the PI, would interfere with the patient's participation in the study or interpretation of their data (i.e., terminal illness, unstable psychiatric condition, etc.)
• Does not understand English

Sponsors & Collaborators

• NuvoAir Medical PC: lead
• Optum, Inc.: collaborator

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

• Ken Cohen, MD

  Executive Director of Translational Research, OptumCare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Harker, MD

CONTACT

(303)748-5781; eric.harker@nuvoair.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pragmatic evaluation of a clinical service using a prospective cohort comparison of intervention vs propensity matched controls.

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: April 23, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share