NuvoAir Clinical Service for COPD

(PROMISE Trial)

Overseen By Eric Harker, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NuvoAir Medical PC

Disqualifiers: Terminal illness, Substance abuse, Unstable mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the NuvoAir Clinical Service treatment for COPD?

Research shows that services similar to the NuvoAir Clinical Service, like specialized COPD care services, can improve follow-up care and patient education, reduce hospital readmissions, and are cost-effective by preventing unnecessary hospital admissions and supporting home treatment. ^{1 2 3 4 5}

What makes the NuvoAir Clinical Service treatment for COPD unique?

The NuvoAir Clinical Service for COPD is unique because it offers a virtual-first approach, allowing patients to receive care remotely, which can enhance accessibility and convenience compared to traditional in-person treatments. This service may include telehealth components, enabling real-time interaction and support for patients at home, which is particularly beneficial for managing chronic conditions like COPD. ^{3 4 6 7 8}

Research Team

Jeffrey Vanwormer

Principal Investigator

Marshfield Clinic

Eligibility Criteria

This trial is for people over 30 years old with COPD, including conditions like emphysema and chronic bronchitis. Participants must have been diagnosed in the last two years and need access to a smartphone or telephone.

Inclusion Criteria

I have been diagnosed with COPD in the last 2 years.

I am 30 years old or older.

You are able to use a smartphone, cell phone, or landline telephone.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive routine clinical care with the addition of the NuvoAir Clinical service, including comprehensive monitoring and personalized interventions

12 months

Virtual interactions with NuvoAir Coach and care coordinator

Follow-up

Participants are monitored for health outcomes using health insurer or provider records

12 months

Treatment Details

Interventions

• NuvoAir Clinical Service

Trial Overview The study tests if the NuvoAir Clinical Service can reduce severe flare-ups, hospital visits, emergency room trips, and overall costs of care for COPD patients compared to those not using this service over a period of 12 months.

Participant Groups

Group I: Standard Care Experimental Treatment 0 Interventions

Propensity matched controls with COPD who receive usual care.

Group II: NuvoAir Clinical service Experimental Treatment 1 Intervention

Patients with COPD receiving usual care plus NuvoAir clinical services.

NuvoAir Clinical Service is already approved in United States, European Union for the following indications:

Approved in United States as NuvoAir Clinical Service for:

• Chronic Obstructive Pulmonary Disease (COPD) management

Approved in European Union as NuvoAir Clinical Service for:

• Chronic Obstructive Pulmonary Disease (COPD) management

Who Is Running the Clinical Trial?

NuvoAir Medical PC

Lead Sponsor

Trials

2

Recruited

1,600+

Findings from Research

The asthma/COPD service (AC service) effectively assessed around 60% of patients with airway symptoms in the northern Netherlands from 2007 to 2014, leading to improved management of asthma and COPD.

Patients who received advice from pulmonologists showed significant improvements, with a reduction in unstable COPD cases from 67% to 50% and unstable asthma cases from 3% to 24%, indicating the service's efficacy in enhancing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Asthma/COPD service in general practice. Study into feasibility and effectiveness]. Metting, EI., Riemersma, RA., Kocks, JW., et al.[2018]

A chronic obstructive pulmonary disease (COPD) care service enhances timely access to follow-up care for patients transitioning from hospital to home, which is crucial for their recovery.

This service also improves patient education during the transition, helping patients better understand their condition and manage their health effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing COPD Readmission Rates: Using a COPD Care Service During Care Transitions. Portillo, EC., Wilcox, A., Seckel, E., et al.[2023]

The establishment of an acute respiratory assessment service in a hospital significantly helps manage COPD patients by preventing unnecessary hospital admissions and providing home treatment when suitable.

An economic evaluation of the service showed that it is cost-effective, indicating that it not only improves patient care but also reduces healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cost-effectiveness of outreach respiratory care for COPD patients. Gordois, A., Scuffham, P., Gibbons, D.[2006]

The implementation of a respiratory clinical-nurse-specialist-led COPD in-reach service significantly reduced the average length of hospital stay for COPD patients by 2.53 days.

This service also decreased readmission rates by an average of 4.5 per month and improved patient experience, with 17% of patients benefiting from an early assisted discharge scheme.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a specialist-nurse-led 'COPD in-reach service'. Cope, K., Fowler, L., Pogson, Z.[2016]

An observational study found that an integrated hospital and community-based care model for COPD patients resulted in similar outcomes to previous studies, with early discharge care lasting about 9.37 days and a 21.1% readmission rate within 60 days.

The prevention of admission care lasted five to six days with a 34.1% readmission rate and a 3.8% death rate within 60 days, suggesting that this community model could effectively expand hospital-at-home services for COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital at home for chronic obstructive pulmonary disease: an integrated hospital and community based generic intermediate care service for prevention and early discharge. Davison, AG., Monaghan, M., Brown, D., et al.[2018]

Telehealth with video components for real-time pulmonary rehabilitation is feasible and acceptable for COPD patients, suggesting it can effectively support their rehabilitation at home.

The review of seven studies indicates that telehealth can offer clinical and social benefits for COPD patients, but there remains a knowledge gap regarding its overall effectiveness and acceptance in rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering Pulmonary Rehabilitation for Patients with Chronic Obstructive Pulmonary Disease at Home Using Telehealth: A Review of the Literature. Almojaibel, AA.[2020]

The Newcastle tertiary care multidisciplinary respiratory service effectively manages complex airway diseases like severe asthma and COPD through a comprehensive, person-centered approach known as the 'Treatable Traits' model, which has been in place for nearly 30 years.

The service includes various specialized clinics and a team of diverse healthcare professionals, ensuring tailored assessments and interventions for patients, which has been crucial in accommodating the growing demand for complex airway disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary care in chronic airway diseases: the Newcastle model. McDonald, VM., Harrington, J., Clark, VL., et al.[2022]

A survey of 55 clinicians and 19 patients with COPD revealed that remote care delivery is widely accepted, with clinicians feeling capable of assessing symptoms and providing support for smoking cessation remotely.

Consensus was reached on the appropriateness of remote care for several activities, including collecting health information (77% agreement) and reinforcing smoking cessation (81% agreement), indicating that many aspects of COPD management can be effectively conducted online.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specialty COPD care during COVID-19: patient and clinician perspectives on remote delivery. Wu, F., Burt, J., Chowdhury, T., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

[Asthma/COPD service in general practice. Study into feasibility and effectiveness]. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Reducing COPD Readmission Rates: Using a COPD Care Service During Care Transitions. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The cost-effectiveness of outreach respiratory care for COPD patients. [2006]

4. England pubmed.ncbi.nlm.nih.gov

Developing a specialist-nurse-led 'COPD in-reach service'. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Hospital at home for chronic obstructive pulmonary disease: an integrated hospital and community based generic intermediate care service for prevention and early discharge. [2018]

6. India pubmed.ncbi.nlm.nih.gov

Delivering Pulmonary Rehabilitation for Patients with Chronic Obstructive Pulmonary Disease at Home Using Telehealth: A Review of the Literature. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Multidisciplinary care in chronic airway diseases: the Newcastle model. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Specialty COPD care during COVID-19: patient and clinician perspectives on remote delivery. [2021]