COPDPROMISENCT05955482
Pragmatic Assessment of the NuvoAir Clinical Service in the Management of Patients With Chronic Obstructive Pulmonary Disease
An observational study of COPD and Comorbidities and Coexisting Conditions, run by NuvoAir Medical PC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- COPD, Comorbidities and Coexisting Conditions
- What is being tested?
- NuvoAir Clinical Service
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2023to Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A propensity matched comparison group will be selected from the same insured population (Security Health Plan of Wisconsin): Patients with COPD of comparable COPD severity, age, gender from the same region and type of health insurance (Medicare Advantage).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Marshfield Clinic Research Institute
Marshfield, Wisconsin, 54449
About this study
Official title: PROMISE: Pragmatic Assessment of the NuvoAir Clinical Service in the Management of Patients With Chronic Obstructive Pulmonary Disease
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.
Read the detailed 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.
- Conditions
- COPD, Comorbidities and Coexisting Conditions
- Being tested
- NuvoAir Clinical Service
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuvoAir Clinical ServiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| NuvoAir Clinical service | Patients with COPD receiving usual care plus NuvoAir clinical services. Receives: Other: NuvoAir Clinical Service | |
| Standard Care | Propensity matched controls with COPD who receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate & Severe Exacerbations
Rate of moderate and severe exacerbations of COPD, measured by the health insurer or provider's records.
Measured: 12 months
Secondary outcomes (3)
Readmissions
Rate of hospital readmission in 30 days following COPD related hospitalization
Measured: 30 days post admission
Hospital days
Median number of hospital days
Measured: 12 months
Cost of care
Total cost of care as measured by insurer claims data
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start24 Jul 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuvoAir Medical PC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey VanWormer, PHD, Principal investigator, Marshfield Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955482
- Sponsor's protocol ID
- 50M16FSHP
- Acronym
- PROMISE
- Status last verified
- May 2025
- First submitted
- 13 Jul 2023
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROMISE: Pragmatic Assessment of the NuvoAir Clinical Service in the Management of Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05955482
- Acronym / sponsor ID
- PROMISE / 50M16FSHP
- Conditions
- COPD, Comorbidities and Coexisting Conditions
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- NuvoAir Medical PCIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NuvoAir Clinical service | – | Other: NuvoAir Clinical ServicePatients with COPD receiving usual care plus NuvoAir clinical services. |
| Standard Care | – | –Propensity matched controls with COPD who receive usual care. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A propensity matched comparison group will be selected from the same insured population (Security Health Plan of Wisconsin): Patients with COPD of comparable COPD severity, age, gender from the same region and type of health insurance (Medicare Advantage).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NuvoAir Clinical ServiceThe 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. | Other | NuvoAir Clinical service |
Primary outcome
Moderate & Severe Exacerbations
Time frame: 12 months
Rate of moderate and severe exacerbations of COPD, measured by the health insurer or provider's records.
3 secondary outcomes
Readmissions
Time frame: 30 days post admission
Hospital days
Time frame: 12 months
Cost of care
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey VanWormer, PHD principal investigator
Marshfield Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Comorbidities and Coexisting Conditions, run by NuvoAir Medical PC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate & Severe Exacerbations (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.