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

COPD Clinical Trial

— PROMISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05955482
• Other study ID #: 50M16FSHP
• Status: Recruiting
• Start date: July 24, 2023
• Est. completion date: July 2025

Study information

• Verified date: December 2023
• Source: NuvoAir Medical PC
• Contact: Eric Harker, MD
• Phone: 3037485781
• Email: eric.harker[@]nuvoair.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Description: The program will be a virtual (decentralized), pragmatic evaluation of an implementation of the NuvoAir Clinical service for patients with COPD residing in the United States of America and who are enrolled with one or more health insurers or providers supporting the program. The evaluation will be organized around two cohorts; Patients with an ICD10 code for COPD (in the health insurer's or provider's database); - Who use the NuvoAir Clinical service vs those - Who undergo standard care (matched control - no intervention) Each patient in the NuvoAir cohort will receive their routine clinical care from their primary care provider 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 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. Each patient in the standard care cohorts will receive their routine clinical care from their healthcare provider as usual. Only anonymized 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), geographic place and period of entry into the program. The program period will include 1 year of active participation (for NuvoAir users) followed by 1 year of follow-up using health insurer or provider records. Objectives: To determine if use of the NuvoAir clinical service results in a lower rate and number of moderate and severe exacerbations of COPD, lower readmissions due to COPD exacerbation within a 30-day period following a COPD exacerbation, lower days in hospital and lower healthcare costs compared with the matched cohorts of standard care patients who do not use the NuvoAir clinical service. To determine if use of the NuvoAir results in reduced readmissions due to COPD during the 30-day period following an exacerbation, improved health status and improved adherence compared with prior to the program/baseline.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

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 Exclusion Criteria: 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

Related Conditions & MeSH terms

• Comorbidities and Coexisting Conditions
• COPD
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 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 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.

Locations

Country	Name	City	State
United States	Marshfield Clinic Research Institute	Marshfield	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
NuvoAir Medical PC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Moderate & Severe Exacerbations	Rate of moderate and severe exacerbations of COPD, measured by the health insurer or provider's records.	12 months
Secondary	Readmissions	Rate of hospital readmission in 30 days following COPD related hospitalization	30 days post admission
Secondary	Hospital days	Median number of hospital days	12 months
Secondary	Cost of care	Total cost of care as measured by insurer claims data	12 months