Overview

N-of-1 trials are the gold standard study design to evaluate individual treatment effects and derive personalized treatment strategies. Digital tools have the potential to initiate a new era of N-of-1 trials in terms of scale and scope, but fully-functional platforms are not yet available. Here, we present the StudyU platform which includes the StudyU designer and StudyU app. With the StudyU designer, scientists are given a web application to digitally specify, publish, and conduct N-of-1 trials. The StudyU app is a smartphone application with innovative user-centric elements for participants to partake in the published trials and assess the effects of different interventions on their health. Thereby, the StudyU platform allows clinicians and researchers worldwide to easily design and conduct digital N-of-1 trials in a safe manner. We envision that StudyU can change the landscape of personalized treatments both for patients and healthy individuals, as a free collaborative tool for researchers, and as a tool that can be integrated in clinical practice.

StudyU was initiated in Master project in summer 2020: “App-based N-of-1 trials in a clinically-relevant context for personalizing digital health interventions”. 

This project is embedded in different project on N-of-1 trials and digital health interventions, see here for more details.

• Talk at the Berlin Epidemiological Methods Colloquium: https://www.youtube.com/watch?v=_KaGearXQkI

• The StudyU platform contains the StudyU designer and the StudyU app, which allow to design and implement, and then to conduct the study, respectively.

• You can find the StudyU app here in the Android Play store and here in the Apple App store.

• You can find web versions of the StudyU designer at designer.studyu.health and of the StudyU app at app.studyu.health.

• See here for our StudyU github repository with all source code of the platform.

• Here are the impressum, terms of use, and privacy policies for using StudyU:

  • Imprint (English, German)

  • Terms of use of the StudyU Designer (English, German)

  • Privacy policies of the StudyU Designer (English, German)

  • Terms of use of the StudyU App (English, German)

  • Privacy policies of the StudyU App (English, German)

• Ongoing clinical studies that are using StudyU:

  • FAB Study: Free of Antidepressiva - clinical support when stopping the use of antidepressive medication through open-label placebo (link)

You can find the preprint of our manuscript with a full description of StudyU here:

Konigorski S, Wernicke S, Slosarek T, Zenner AM, Strelow N, Ruether FD, Henschel F, Manaswini M, Pottbäcker F, Edelman JA, Owoyele B, Danieletto M, Golden E, Zweig M, Nadkarni G, Böttinger E (2020). StudyU: a platform for designing and conducting innovative digital N-of-1 trials. arXiv:2012.14201. https://arxiv.org/abs/2012.14201.

Team:

• Stefan Konigorski
• Tamara Slosarek
• Sarah Wernicke
• Alexander Zenner
• Nils Strelow
• Fabian Pottbäcker
• Manisha Manaswini
• Darius Ruether
• Florian Henschel
• Erwin Böttinger

Overview

N-of-1 trials are multi-crossover self-experiments that allow individuals to systematically evaluate the effect of interventions on their personal health goals. Although several tools for N-of-1 trials exist, none support non-experts in conducting their own user-centric trials. Here, we have developed StudyMe, an open-source mobile application that offers users flexibility and guidance in configuring every component of their trials. Through an initial survey with 272 participants, we learned that individuals are interested in a variety of personal health aspects and have unique ideas on how to improve them. In an iterative, user-centered development process with intermediate user tests, we developed StudyMe that features an educational part to communicate N-of-1 trial concepts. A final empirical evaluation of StudyMe showed that all participants were able to create their own trials successfully using StudyMe and the app achieved a very good usability rating. Our findings suggest that StudyMe provides a significant step towards enabling individuals to apply a systematic science-oriented approach to personalize health-related interventions and behavior modifications in their everyday lives.

• An illustrative video of StudyMe can be found here.

• The StudyMe app is currently available for Android. You can find the StudyMe app here in the Android Play store.

• See here for our StudyMe github repository with all source code of the platform.

• Here are the impressum, terms of use, and privacy policies for using StudyMe:

  • Imprint

  • Terms of use

  • Privacy policy

  • Acknowledgements

You can find the preprint of our manuscript with a full description of StudyMe here:

Zenner AM, Böttinger E, Konigorski S (2021). StudyMe: a new mobile app for user-centric N-of-1 Trials. arXiv:2108.00320. http://arxiv.org/abs/2108.00320.

People:

• Alexander Zenner (http://zenner.org)
• Stefan Konigorski
• Erwin Böttinger