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

April 18, 2024 updated by: NuvoAir Medical PC
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.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

1050

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care
Propensity matched controls with COPD who receive usual care.
Experimental: NuvoAir clinical service
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.
Patients with COPD receiving usual care plus NuvoAir clinical services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Moderate & Severe Exacerbations
Time Frame: 12 months
Rate of moderate and severe exacerbations of COPD, measured by the health insurer or provider's records
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe COPD Exacerbations
Time Frame: 12 months
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
Major Adverse Cardiac Event
Time Frame: 12 months
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
30-Day COPD Related Readmissions
Time Frame: 12 months
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
All-Cause Hospitalizations
Time Frame: 12 months
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
All-Cause Readmissions
Time Frame: 12 months
Number of all cause readmissions within a 30 day period following a COPD exacerbation, compared with the standard care cohort
12 months
Days Hospitalized due to COPD
Time Frame: 12 months
Total number of days hospitalized due to COPD exacerbation, compared to the standard care cohort
12 months
Cost of Care Related to COPD
Time Frame: 12 months
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
Medication Adherence
Time Frame: 12 months
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
Quality of Life (QOL)
Time Frame: 12 months
Quality of life measured using the SGRQ-C collected at baseline and at the end of the study
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-Acting Beta-Agonists Used
Time Frame: 12 months
Number of short-acting beta-agonists used in one year from health insurer or provider records compared with the standard care cohort
12 months
Courses of Oral Antibiotics/Steroids
Time Frame: 12 months
Number of courses of oral antibiotics/steroids in one year from health insurer or provider records compared with the standard care cohort
12 months
Self-efficacy
Time Frame: 12 months
Self-efficacy for managing chronic disease scale score baseline vs end of study in NuvoAir cohort only
12 months
Patient Activation
Time Frame: 12 months
Patient activation measure score baseline vs end of study in NuvoAir cohort only
12 months
Cat Score
Time Frame: 12 months
CAT score baseline vs end of study in NuvoAir cohort only
12 months
mMRC Dyspnea Scale
Time Frame: 12 months
mMRC dyspnea scale score baseline vs end of study in NuvoAir cohort only
12 months
Physical Activity
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Ken Cohen, MD, Executive Director of Translational Research, OptumCare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 25, 2023

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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