Observational studies are a vital tool for gathering data to assess the effectiveness of treatments in the real world. They can be highly informative but should be “low touch” with researchers having limited patient interaction during treatment, instead relying on information captured through the normal course of everyday life.
In this study, the client required a data capture solution for an atopic dermatitis registry that would support a two-and-a-half-year observational study of 600 patients across ten countries. Several validated instruments needed to be incorporated into the design with both remote and on-site data capture at quarterly intervals.
The challenge was to develop a solution that would engage participants for an extended period of time while not influencing their behavior.Matt McCarty
Chief Strategy and Marketing Officer, Clario
Clario’s Post-Approval platform delivered the required validated assessments remotely through a native application, downloadable on to patients’ own iOS and Android smartphones. To maximize participation, devices were also provisioned to around 20% of patients who did not have an appropriate smart device. Sites were supplied with tablet devices with the assessment app pre-installed to ensure that patients could still complete their assessments during site visits, even in the event that they did not have their device with them. To meet the client’s requirement of providing low-level engagement, reminders, guidance messaging and tailored training were all delivered as part of the app. Finally, the client was able to monitor patient and site progress via the study portal.
Using a BYOD approach allowed the study to integrate into patients’ everyday lives, while the intuitive user experience and interface design with built-in messaging helped maintain participation rates for the duration of the study. For the client, the use of flexible BYOD data capture capability dramatically reduced costs in comparison to a fully provisioned model.
McCarty concludes, “This observational study clearly shows that a BYOD approach can be adopted even when using validated instruments. The completion rates for both site and remote data capture were extremely high, reaching over 90% for remote capture. As a result, the client extended the study by another two and a half years to collect further valuable data for analysis.”