ScaleMed: A methodology for iterative mHealth clinical trials

mHealth, which involves using smartphones as a tool for healthcare monitoring and delivery, continues to gain traction worldwide. As a result, new pilot programs and clinical trials continue to be launched to establish clinical evidence. However, the continual need for software changes between iterations of the trial creates a lengthy time loop between clinical researchers requesting a change and software developers implementing the requested change. We propose a new methodology for performing clinical trials, called ScaleMed. The ScaleMed methodology involves decoupling low-level app functionality from high-level trial-related operational parameters, a common software development practice. By utilizing a centralized website that allows clinical researchers to rapidly update these trial parameters, iterative clinical trials have the potential to move at a much faster rate than in current practice. We demonstrate an example of the ScaleMed methodology applied to an ongoing mental health trial (codenamed Lucy). In addition, we conducted a separate trial on the usability of the ScaleMed-enabled Lucy platform and found a predominantly positive response from the potential clinical users. In our limited trials, we showed that the time to make changes to app parameters was cut from weeks to less than a minute.