NuvoAir Clinical Service for COPD
(PROMISE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: NuvoAir Medical PC
Disqualifiers: Terminal illness, Substance abuse, Unstable mental illness, others
No Placebo Group
Approved in 2 Jurisdictions
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.
12345What 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.
34678Eligibility 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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Standard CareExperimental Treatment0 Interventions
Propensity matched controls with COPD who receive usual care.
Group II: NuvoAir Clinical serviceExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Marshfield Clinic Research InstituteMarshfield, WI
Loading ...
Who Is Running the Clinical Trial?
NuvoAir Medical PCLead Sponsor
References
[Asthma/COPD service in general practice. Study into feasibility and effectiveness]. [2018]A study of the effectiveness and functioning of an asthma/COPD service (AC service).
Reducing COPD Readmission Rates: Using a COPD Care Service During Care Transitions. [2023]A chronic obstructive pulmonary disease care service improves timely access to follow-up care and patient education at the time of transition from hospital to home.
The cost-effectiveness of outreach respiratory care for COPD patients. [2006]An acute respiratory assessment service was established in a hospital that serves an area with a large number of COPD patients. The service aims to prevent unnecessary hospital admissions and provides a detailed patient assessment, treatment at home where appropriate and support. An economic evaluation demonstrated that the service was also cost effective.
Developing a specialist-nurse-led 'COPD in-reach service'. [2016]To develop and implement a respiratory clinical-nurse-specialist-led chronic obstructive pulmonary disease (COPD) 'in-reach service' for an emergency admission unit within a large acute county hospital.
Hospital at home for chronic obstructive pulmonary disease: an integrated hospital and community based generic intermediate care service for prevention and early discharge. [2018]Recent randomized controlled studies have reported success for hospital at home for prevention and early discharge of chronic obstructive pulmonary disease (COPD) patients using hospital based respiratory nurse specialists. This observational study reports results using an integrated hospital and community based generic intermediate care service. The length of care, readmission within 60 days and death within 60 days in the early discharge (9.37 days, 21.1%, 7%) and the prevention of admission (five to six days, 34.1%, 3.8%) are similar to previous studies. We suggest that this generic community model of service may allow hospital at home services for COPD to be introduced in more areas.
Delivering Pulmonary Rehabilitation for Patients with Chronic Obstructive Pulmonary Disease at Home Using Telehealth: A Review of the Literature. [2020]Pulmonary rehabilitation is recommended to restore chronic obstructive pulmonary disease (COPD) patients' abilities to the highest level of independency and functionality. Telehealth has the potential to improve rehabilitation programs and to enhance patients' participation. However, little is known about the potential benefits of using telehealth in providing rehabilitation for COPD patients at home. The purpose of this review was to provide a narrative synthesis of literature of studies, which use telehealth with video components to provide real-time pulmonary rehabilitation for COPD patients. An electronic database search was performed in the Ovid Medline, CINAHL, and PubMed databases. Seven eligible studies were included based on the inclusion criteria. Based on the included studies, using telehealth to provide real-time interactive pulmonary rehabilitation for COPD patients at home is feasible and acceptable, and can provide clinical and social positive benefits. A knowledge gap regarding feasibility, acceptance, and benefits of using telehealth to provide real-time pulmonary rehabilitation services still exists.
Multidisciplinary care in chronic airway diseases: the Newcastle model. [2022]Chronic airway diseases including asthma and COPD are prevalent and high-burden conditions with the majority of patients successfully managed in the primary care setting. However, for some patients with more complex disease such as difficult-to-treat or severe asthma, or complex COPD, tertiary care is required. This review provides an overview of the successful tertiary care multidisciplinary respiratory service that operates in Newcastle, New South Wales, Australia, which has been integrated into the tertiary care outpatient clinics for almost three decades. The service is multifaceted in terms of the clinical care it provides; it includes an "Inpatient Service", "Asthma Management Service", "Difficult Airways Clinic", "Drug Administration Clinic", "Rapid Access Clinic" and "Pulmonary Rehabilitation", and has an integrated research programme. The core of the multidisciplinary approach to airway diseases is a person-centred model of care, the "Treatable Traits" approach. The staffing of this service comprises consultant physicians, respiratory advanced trainees, respiratory scientists, physiotherapists, speech pathologists, nurse specialists and a nurse consultant. Patients that present to this service undergo an initial assessment and clinical review by team members, synthesis of relevant data, and development of a diagnosis and management plan. Based on this clinical review, specific interventions are determined according to the traits identified. Over time the service has evolved to accommodate the increasing numbers of patients requiring access to the Difficult Airways Clinic assessment and therapies. This has been facilitated by partnering with the Centres of Excellence in Severe Asthma and Treatable Traits to develop educational and practice management tools.
Specialty COPD care during COVID-19: patient and clinician perspectives on remote delivery. [2021]The COVID-19 pandemic has impacted specialty chronic obstructive pulmonary disease (COPD) care. We examined the degree to which care has moved to remote approaches, eliciting clinician and patient perspectives on what is appropriate for ongoing remote delivery.