In the coming months, the NuvoAir team will release a series called The Power of Remote, in it highlighting the paramount benefits of remote participation in clinical trials, a key component of decentralized clinical trials. The patient-centric approach of decentralized trials aims to improve the participants’ experience by bringing aspects of the study to the patients through technology.
In the age of a pandemic, we’re witnessing the power of remote, first hand, on a recurring basis—from personal to professional, recreational to requirement. And healthcare is no exception, as there’s been a massive shift from in-clinic participation to at-home involvement.
Through The Power of Remote series, a deeper dive into the various benefits of remote participation will provide further insight into how remoteness can fully be leveraged in this space. In this go-round, you’ll get a closer look at the concept of reducing the patient’s burden.
“A clinical trial is already an unfamiliar experience for patients and we do understand they, as well as their caregivers, need to live a normal life," NuvoAir Founder & CEO, Lorenzo Consoli, attests. “Understanding their living conditions, their technology awareness, what matters to them and their fears is extremely important.” Together, this ensures patients are properly onboarded, educated and engaged through the duration of the study.
But what does “patient burden” actually mean? Whether it’s the weight of the treatment itself or the situational burden within trial participation, the hypothetical “workload” that patients must perform in response to their healthcare needs can have a serious impact on their wellbeing and willingness to enroll and comply with study requirements. The effects on mental health, compounded by existing emotional, mental, and physical stress from living with a chronic illness, can discourage many from making the commitment to clinical trials. With remote participation, however, there are countless opportunities to lessen this burden.
Quite simply, remote participation is easier and less stressful for patients. For one, it means participants save considerable time away—whether it’s from work, school or family (or all the above)—and the comfort and relaxed atmosphere of home is an advantage like no other. Using NuvoAir’s home monitoring devices connected to a dedicated study app, participants can collect lung health data on their own, without the aid of clinical personnel - making data collection smooth, fast and simple. Symptom and quality of life surveys can also be tailored in the app and shared via an investigator portal, so all data is saved in one place.
It’s easy to understand why less time at the hospital would be preferable. Along with extra travel and unpleasant reminders of illness, fewer hospital visits reduces the chances of catching Covid-19 or other easily spreadable illnesses that respiratory patients are especially vulnerable to.
NuvoAir’s user-focused design is another plus for patient experience. NuvoAir’s sleek and small Bluetooth monitoring devices are less likely to conjure negative feelings associated with traditional hospital settings and bulky medical devices. The NuvoAir clinical trials kit, prepared for each participant, is purposefully designed to evoke a memorable unboxing experience.
Beyond the reduction of patient burden, NuvoAir creates a clinical trial experience that expands the trial opportunity to patients who don't live within reasonable limits of a relevant site. Virtually any demographic can be provided access to participate, regardless of locale or Wi-Fi access, as NuvoAir provides a study-specific kit for each participant, including a smartphone with study app and international sim card, ultimately increasing the pool and accelerating recruitment. NuvoAir’s solution, in this way, promotes considerable diversity in trial participation—which is something that has been historically lacking in this space.
These combined benefits heighten convenience and greatly improve participant experience, which can positively affect study enrollment as well as study retention. In a survey conducted by NuvoAir, 73% of the surveyed clinical trial sites rated NuvoAir’s impact on participants’ willingness to enroll in a study as good or excellent and over 75% of site staff reported good or excellent impact on patient retention.
If you’re wondering if patients can successfully collect quality data from home, here are three studies to sway you:
The first, from the Royal Brompton Hospital, shows that the quality of 783 unsupervised home spirometry sessions performed by 37 adult patients with NuvoAir, over nearly one year, was equivalent to the quality of the first supervised spirometry session at the hospital with NuvoAir.
Results from the second study, conducted at the Royal London Hospital, show that 74% of 30 adolescent cystic fibrosis (CF) and bronchiectasis patients were able to perform reproducible spirometry over a six week period according to the European Respiratory Society (ERS)/American Thoracic Society (ATS) technical standards. These tests were performed at home and independently, without clinician supervision.
A Swedish study from the Sahlgrenska University Hospital, which piloted virtual clinics supported by NuvoAir, displays that children aged 6-17 years old with CF could perform correct spirometry tests at home according to ATS/ERS criteria.
As to the quality of data, three validation studies with 200-patients each across various respiratory conditions have demonstrated that NuvoAir’s Air Next spirometer is comparable to Gold Standard office spirometry.
New technology-driven opportunities can greatly reduce the burden on patients to participate in clinical trials while maintaining reliable data collection. These findings offer a clear way forward in the ways we research the safety and efficacy of new drug discoveries.
For more information about NuvoAir's clinical trial solution, please email email@example.com.