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 is fully open-source, has been initiated and further developed in to date 5 master projects, by >10 student assistants ant more collaborators.

• 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)

• FAB Study: Free of Antidepressiva - assessing open-label placebo treatment for antidepressant discontinuation symptoms: study homepage, trial registration, protocol paper (UKE Hamburg, HSU)

• ASIP Study: Evaluation of easy-to-implement anti-stress interventions in a series of N-of-1 trials: trial registration, protocol paper (Charité Berlin)

• Effect of fasting on side effects in endocrine therapy with aromatase inhibitors in breast cancer survivors (Charité Berlin, RB Hospital Stuttgart, University of Würzburg)

• Effect of participant-selected interventions on sleep health (HPI)

• Effect of acne creams on acne severity through smartphone pictures: paper (Harvard University)

• Effect of non-pharmacological interventions to improve chronic pain in clinical care (University of Queensland, Australia)

• Comparison of different drug dosages in health failure patients (Weill Cornell Medicine, New York, USA)

• Adaptive N-of-1 trials of physical exercise on pain in endometriosis patients: paper (Mount Sinai Hospital, New York, USA)

• Comprehensive Exploration of User and Clinician Engagement Motivations and Experiences Using the StudyMe platform and StudyU Apps (Ghana)

• 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 (2022). StudyU: a platform for designing and conducting innovative digital N-of-1 trials. J Med Internet Research  24(6): e35884. https://doi.org/10.2196/35884.
• Müller A, Konigorski S, Meißner C, Fadai T, Warren CV, Falkenberg I, Kircher T, Nestoriuc Y (2023). Study Protocol: Combined N-of-1 Trials to Assess Open-Label Placebo Treatment for Antidepressant Discontinuation Symptoms [FAB-study]. BMC Psychiatry 23: 749. https://doi.org/10.1186/s12888-023-05184-y
• Vetter VM, Kurth T, Konigorski S (2024). Evaluation of easy-to-implement anti-stress interventions in a series of N-of-1 trials: Study protocol of the Anti-Stress Intervention Among Physicians Study (ASIP). medRxiv. https://www.medrxiv.org/content/10.1101/2024.04.22.24306161v1

Team:

• Stefan Konigorski
• Johannes Vedder
• Ibrahim Oezkan 
• Md Raju Ahmed 
• Juliana Schneider
• Thomas Gärtner

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