Clinical trials demand a standardized approach to data collection, especially when it comes to patient-reported outcomes (PRO). In the ever-evolving landscape of mobile technologies, smartphones play a pivotal role in gathering crucial information from clinical trial participants. Much of the emphasis in recent years has centered on the advantages of a bring-your-own-device (BYOD) model in which clinical trial participants use their own smartphones to provide patient-reported outcomes data.

However, the majority of clinical studies employing ePRO use a provisioned device model where participants are provided with a standard handset containing the ePRO application for the duration of the trial. Even in BYOD studies, to prevent selection bias by excluding non-BYOD participants, on average around 20% of participants are provided with a study device as they are unable or unwilling to use their own. With the background of rapid turnover of consumer devices, this poses a challenge for ePRO providers in needing to seek and validate alternative models on a regular basis. That’s where non-consumer smartphones help: They offer the same global reach but with fewer model variants, enhanced performance, and extended longevity.

We selected and evaluated the Santok STK, a non-consumer device, to explore its potential as a reliable tool for home-based ePRO measure administration. Here’s what we learned from this usability testing.  

Method

Our approach was twofold: an in-house technical performance evaluation and external user testing. The former involved comparing the Santok STK with a high-end consumer smartphone, rating parameters like performance, ease of use, screen quality, battery life, and charging on a 0-5 scale. The latter engaged ten participants in defined tasks, assessing their experiences with the device and an associated ePRO app (Signant SmartSignals eCOA).

Results

Technical Performance Evaluation:

  • The time to load a home screen and initiate the app met expectations.
  • Within-app screen loads were instantaneous.
  • Device weight aligned with consumer smartphones.
  • The mean score of 3.8/5 met our technical performance acceptance criteria.

External User Testing:

  • Participants found most tasks intuitive.
  • Noteworthy performance in perceived screen loading speed (4.1/5), ease of use (3.9/5), touchscreen sensitivity (4.2/5), and screen clarity (4.3/5).
  • The mean usability score of 3.7/5 affirmed that the Santok STK met usability and acceptability criteria across a representative sample of clinical trial participants.

Conclusions

In the dynamic realm of clinical trials, mobile technologies like smartphones are indispensable elements for an eCOA strategy. Non-consumer devices such as the Santok STK offer unique advantages, and our rigorous evaluation confirmed its suitability for ePRO data collection. As Senior Manager of Site and Patient Research at Signant Health, I’m excited about the potential this holds for ensuring complete and compliant data collection in our clinical trials.

 Below, you can download a copy of my poster I presented recently at ISPOR Europe. You might also be interested in my Site & Patient Research eBook containing additional research summaries.

Stay tuned for more research and conclusions as we explore eCOA solutions to optimize participation experience for sites and patients, two of the most important stakeholders in clinical research!

scientific poster

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Katie Garner

Advisor - Therapeutic Areas

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