Mobile App and Wearable Integration to Collect Longitudinal Data for SISCAPA Assay Technologies

Client Challenge

SISCAPA Assay Technologies, a leader in high-precision protein analytics focused on understanding longitudinal changes in health and disease, was in the market for a smartphone-driven data collection solution for its studies gathering longitudinal health insights from participants via daily blood sampling. Although it had been generally concluded in the research industry that frequent collection of blood samples would be too cumbersome for many participants, SISCAPA was confident this barrier could be overcome with the right patient-centric technology. They also understood that to be in the data business, the data must be of the highest quality. This conclusion heavily influenced SISCAPA’s efforts to find a solution that would enable them to pair their SampleDiary™ daily blood sampling kit with a mobile data collection app for supplementary electronic patient-reported outcomes (ePROs). 

With a goal to limit the blood sample and ePRO completion to just 1-2 minutes per day, it was crucial that the chosen platform streamline the data collection process as much as possible for study participants. Initially, SISCAPA engaged consultants to explore the development of  their own mobile app; quickly, they determined this would be too resource-intensive for the SISCAPA team to support over time. 

Next, SISCAPA vetted the eClinical market to identify technology vendors that offered a solution to support their unique needs. After evaluating six vendors, the SISCAPA team pinpointed a specific mobile-oriented data collection and study management platform that would be optimal for accomplishing their plans. This solution fulfilled their primary objective to gather data remotely and access it within a cloud-based repository throughout the duration of the study. 

Client Needs

• Native mobile app for ePRO data collection of free-form health comments at the time of sampling and a number of specific health parameters gathered through wearable sensors or bluetooth enabled devices, such as heart rate variability, sleep metrics, weight, temperature, blood pressure, etc.
• Ability for participants to capture a digital photo of their daily blood sampling in the mobile app with date and time stamp
• User-friendly interface for the SISCAPA research team and study participants
• HIPAA compliant solution
• Capable of accommodating international trials
• Scalable for SISCAPA’s continued growth

Resolution

SISCAPA connected with Crucial Data Solutions (CDS) to discuss how CDS’ platform, TrialKit, could help them collect patient data from anywhere via mobile app. While assessing TrialKit, SISCAPA discovered the platform’s out-of-the-box integration capabilities with Apple Watch would allow them to collect a wider variety of endpoints than initially planned. This functionality and straightforward setup provided them with the opportunity to continuously collect data on a variety of health metrics they didn’t expect to be able to gather remotely. These included key endpoints such as heart rate variability, resting heart rate, sleep patterns, ECG, daily activity rings, and blood oxygen (SpO2) levels.

SISCAPA and CDS saw this as an opportunity to initiate a leading-edge study approach that seamlessly united data from three distinct modalities: SISCAPA’s daily blood sampling solution, TrialKit’s mobile app (i.e., ePRO), and wearable sensors (i.e., Apple Watch). All data from the study would be submitted remotely by participants and made accessible to SISCAPA in real-time through TrialKit’s secure cloud database.

In less than a week’s time, the SISCAPA team was trained on how to design, configure and manage their study database in the TrialKit platform. Over the course of a few days, they had created a prototype study – a process they expected to take at least six months to complete prior to learning about TrialKit. The platform’s rapid, user-friendly study configuration and forms design capabilities allowed SISCAPA to hit the ground running and deploy their study in less than two weeks. 

In creating their study, SISCAPA found that simplicity and ease of use were TrialKit’s biggest benefits. Not only was the platform’s drag-and-drop form builder simple and straightforward, the mobile user interface was ideal for SISCAPA’s study participants. The intuitive tap and swipe gestures, photo capture, and QR code scanning were familiar, easy mobile functions to which most users were already accustomed.

Moreover, the support SISCAPA received from CDS was described as “exceedingly good,” but also equipped them to be highly self-sufficient. Any challenges or questions they had along the way were effectively addressed immediately, keeping SISCAPA on track with their study timelines. In their minds, CDS was a true partner versus just a vendor. 

The collaborative nature of working with Crucial Data Solutions was immediately apparent…because of the way customer support and training was set up.

Leigh Anderson, CEO of SISCAPA Assay Technologies

Results

• Successfully launched their study in TrialKit in less than two weeks
• 35 participants each collected 30 to >600 daily samples at home with contextual data from TrialKit
• Study participants are able to enter data daily from anywhere in the world using their own smart device (phone/tablet) in just 1-2 minutes per day
• TrialKit scales with SISCAPA’s needs as they incorporate additional features over time, such as inventory management, eConsent, and the app’s self-enrollment feature for participants to directly register and engage in global registries
• Option to implement other wearables and Bluetooth-connected devices to collect even more key data points in future studies, such as CPAP machines, blood glucose monitors, and smart scales
• Solved issue of development continuity
• Demonstrated that frequent sample collection can be successfully implemented in a patient-centric approach

Client Benefits

SISCAPA reported that CDS exceeded their expectations, as TrialKit empowered them to operate self-sufficiently and accomplish things they previously didn’t know were possible with eClinical technology. SISCAPA believed that “everything is within the realm of possibility regarding what we’d like to do [with TrialKit].” They summarized the benefits they’ve realized to date as follows: 

• Rapid self-service study design and deployment
• High study participant engagement and retention rate around the world
• High quality, direct-from-source data
• Reliable, efficient collection of longitudinal data
• Out-of-the-box integration with a wide variety of wearable devices
• Development of a dynamic, synergistic partnership
• Scalability/flexibility of study size, type and complexity with TrialKit
• Limited manual data entry, resulting in fewer data entry errors and less data cleaning required