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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-100
SponsorNuvoAir Medical PC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • NuvoAir clinical service

    Other intervention

    Patients with COPD receiving usual care plus NuvoAir clinical services.

Treatment groups

1,050 Participants
are divided into 2 treatment groups
Group A: NuvoAir clinical serviceExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Moderate & Severe Exacerbations

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

Time frame
12 months

Secondary outcomes

1

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

Time frame
12 months
2

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

Time frame
12 months
3

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

Time frame
12 months
4

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

Time frame
12 months

Other outcomes

1

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

Time frame
12 months
2

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

Time frame
12 months
3

Self-efficacy

Self-efficacy for managing chronic disease scale score baseline vs end of study in NuvoAir cohort only

Time frame
12 months
4

Patient Activation

Patient activation measure score baseline vs end of study in NuvoAir cohort only

Time frame
12 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NuvoAir Medical PC

Lead sponsor

Optum, Inc.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: