A ResearchKit app to deliver paediatric electronic consent: Protocol of an observational study in adolescents with...

ResearchKit is an open-source software framework designed to streamline the process of screening and consenting participants into research studies. By digitizing traditionally analog processes, ResearchKit has potential to increase the reach, efficiency, and scalability of mobile health (mHealth) research. The model has been successfully applied in adult settings. However, to our knowledge, no group has sought to adapt ResearchKit for a paediatric research environment in Canada. The potential benefits for building paediatric mHealth apps compatible with remote eConsent are numerous: (1) access to studies can be broadened from small groups of children and families who live in close proximity to research sites to whole populations across geographical boundaries, (2) increased convenience for study participants because they can complete consent on their smartphone from their home, rather than in person or on paper, and (3) large-scale study enrollment can be conducted with fewer resources than traditional face-to-face methods. We describe the rationale and design of a proof-of-concept observational study focused on implementing remote eConsent in a Canadian paediatric population. A community-based sample of adolescents with arthritis will be remotely onboarded to use the iCanCope pain self-management app for 8-weeks. Outcomes will focus on: (1) fidelity and acceptability of the eConsent process, (2) fidelity of the iCanCope app in terms of engagement and acceptability, (3) participant study experience including level of perceived support and acceptability of study tasks, and (4) clinical outcomes related to use of the iCanCope app over an 8-week period.