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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06379529
• Other study ID #: USCOPD2022B
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: NuvoAir Medical PC
• Contact: Eric Harker, MD
• Phone: (303)748-5781
• Email: eric.harker[@]nuvoair.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 provider's 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 1,050 patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1050
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• COPD
• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• NuvoAir clinical service
Patients with COPD receiving usual care plus NuvoAir clinical services.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
NuvoAir Medical PC	Optum, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Short-Acting Beta-Agonists Used	Number of short-acting beta-agonists used in one year from health insurer or provider records compared with the standard care cohort	12 months
Other	Courses of Oral Antibiotics/Steroids	Number of courses of oral antibiotics/steroids in one year from health insurer or provider records compared with the standard care cohort	12 months
Other	Self-efficacy	Self-efficacy for managing chronic disease scale score baseline vs end of study in NuvoAir cohort only	12 months
Other	Patient Activation	Patient activation measure score baseline vs end of study in NuvoAir cohort only	12 months
Other	Cat Score	CAT score baseline vs end of study in NuvoAir cohort only	12 months
Other	mMRC Dyspnea Scale	mMRC dyspnea scale score baseline vs end of study in NuvoAir cohort only	12 months
Other	Physical Activity	Average number of steps per day during the 2 week baseline period vs the average number of steps per day during a 2 week period 12 months later in NuvoAir cohort only	12 months
Primary	Moderate & Severe Exacerbations	Rate of moderate and severe exacerbations of COPD, measured by the health insurer or provider's records	12 months
Secondary	Severe COPD Exacerbations	Proportion of patients with at least one episode of severe COPD exacerbation within a 12-month period, NuvoAir cohort vs standard care cohort	12 months
Secondary	Major Adverse Cardiac Event	Proportion of patients using the NuvoAir clinical service who have experienced a major adverse cardiac event (including CHF exacerbations, ACS/AMI, stroke) or all cause death, compared with the standard care cohort, measured using health insurer or provider records and assessed each year of the study	12 months
Secondary	30-Day COPD Related Readmissions	Number of readmissions due to COPD exacerbation within a 30 day period following a COPD exacerbation (NuvoAir cohort only), compared to baseline and the number of 30-day readmissions after hospitalisation due to a COPD exacerbation compared to the standard care cohort	12 months
Secondary	All-Cause Hospitalizations	Proportion of patients using the NuvoAir clinical service who have experienced an all-cause admission to hospital, compared with the standard care cohort, measured using health insurer or provider records and assessed each year of the study	12 months
Secondary	All-Cause Readmissions	Number of all cause readmissions within a 30 day period following a COPD exacerbation, compared with the standard care cohort	12 months
Secondary	Days Hospitalized due to COPD	Total number of days hospitalized due to COPD exacerbation, compared to the standard care cohort	12 months
Secondary	Cost of Care Related to COPD	Cost of care related to COPD, including hospitalization, emergency room visits, urgent care visits, hospital visits, outpatient visits, and pharmacy costs, for those using NuvoAir Home compared with the standard care cohort	12 months
Secondary	Medication Adherence	Percentage of the total doses of medication taken, which is the number of doses taken within a given time divided by the number of doses prescribed by a physician during the same time in NuvoAir cohort only	12 months
Secondary	Quality of Life (QOL)	Quality of life measured using the SGRQ-C collected at baseline and at the end of the study	12 months