NuvoAir’s Decentralized Trial Experience: What’s in a Clinical Trial Kit?

As clear benefits have emerged, the virtualization or decentralization of clinical trials has become a crucial element in study design. A key benefit is that decentralized trials (or hybrid trials, which mix elements of decentralized and traditional trials) offer a more patient-centric approach to studies. Bringing aspects of the study to participants supports an overall improved patient experience and reduces the patient burden involved. NuvoAir’s clinical trial solution does just that by enabling participants to collect respiratory endpoints from the comfort of home. This eliminates unnecessary trips to the clinic study site, saving precious time and resources, and gives people the chance to participate with less disruption of their daily lives. NuvoAir’s solution has seen proven results with improved patient centricity as well as boosted enrollment and retention.

In addition to allowing people the option to participate from home, NuvoAir’s thoughtfully designed Clinical Trial Kit, created for participant convenience, takes the patient experience to the next level. NuvoAir’s deep experience supporting thousands of patients through the NuvoAir Home remote clinical service has provided tremendous insight into the user experience. NuvoAir’s designers are forever focused on elevating the look and feel of products to invoke well sought-after consumer products and to shake off the negative associations with traditional, bulky medical devices patients are used to at the hospital.

Poor study retention can delay drug approvals, but when patient experience is improved, there’s potential for better engagement. The NuvoAir Clinical Trial Kit stands out from the norm. Here’s a look at what’s inside the box.

Ready-to-use Smartphone with ALFA App

NuvoAir’s Clinical Trial Kit takes participants out of the traditional hospital setting and into the 21st century. NuvoAir’s mobile device management (MDM) system ensures that the smartphone provided is pre-loaded with everything they need to get started and comes connected to the Air Next spirometer. An internal sim card and Wi-Fi guarantees connectivity for smooth data collection and ensures access for all participants, enabling studies to enlarge and diversify their enrollment pool.

After an initial meeting at the trial site, during which participants are surveyed for eligibility based on study criteria, key data points like height, weight, and demographics are entered into the NuvoAir investigator portal and a unique participant code is provided. This automatically feeds into the participant’s NuvoAir clinical trial app, ALFA, which is personalized and tailored per trial requirements. Also included is the option for electronic clinical outcome assessments (eCOA) and integration of other devices such as for activity tracking. When the user wants to enter data—however often the trial requires—they simply open the app, and they’re off.

In-app coaching provides personalized feedback on spirometry maneuvers to help participants to improve their technique. If there’s an error, they’ll learn why, so they can change it or make adjustments moving forward—all of this contributes to the collection of quality lung function data. ALFA also includes an integrated feature for video call, enabling clinicians to observe participants during their spirometry test on the same device.

For convenient user reference, the ALFA app features a short instructional video showing participants how to properly take a spirometry test, providing a refresher to the on-site training each participant receives.

Air Next Spirometer

NuvoAir’s clinical trial platform contains the same award-winning spirometer as the NuvoAir Home platform used for clinical service, which is FDA cleared and CE approved. To date, over 1.4 million spirometry sessions have been collected with this spirometer from patients’ homes. The spirometer’s slim and sleek design is in stark contrast to the hospital devices, yet is as reliable in producing quality results according to 3 large validation studies with 200 patients each, comparing the NuvoAir Home platform to Gold standard office spirometry.

Disposable Turbines

Each kit comes with a set amount of disposable turbines which are pre-calibrated, eliminating the potential for user error in calibration, as well as frustration with device handling. Participants simply insert a disposable turbine, a process that’s been approachable for virtually all patients, even those with neuromuscular difficulties.

Phone Stand

A phone stand can be included in the kit as well, which can be particularly useful for studies with observed spirometry via video call or for participants with neuromuscular disorders.

With hundreds of clinical trials underway collecting respiratory endpoints, solutions that make participation easier and more enjoyable are more likely to see improved enrollment and retention rates. If you’re curious to learn more, contact clinicaltrials@nuvoair.com.