Hasso-Plattner-Institut
Prof. Dr. Christoph Lippert
 

StudyU Platform

News

  • Congratulations Pauline and Johannes, and the entire team to being awarded the Best Idea Award at the HPI 2022 with StudyU !! Here is some more information: Link1 and Link2 
  • On June 8, 2023, we had the honor of introducing StudyU to Prof. Dr. Karl Lauterbach, the German Federal Minister of Health, during his visit to the Digital Health Cluster at the Hasso Plattner Institute (HPI). See here for more details.

 

Background

Traditionally, in our health system, treatment guidelines and health recommendations have been developed based on results of studies of large groups of individuals. However, the analysis of such large population-based studies only gives insights into factors affecting diseases and treatments on average. Hence, these results do not allow meaningful predictions whether an intervention will help a given single individual. For example, major drugs in therapeutic areas including asthma, depression, diabetes or rheumatoid arthritis have only shown an efficacy in 50%-60% of patients. Similarly, the effect of health interventions and lifestyle changes on chronic disease and health outcomes on an individual level if often unclear.

N-of-1 trials provide a framework to evaluate personalized treatments and derive invididual treatment effects. More specifically, N-of-1 trials are multi-crossover randomized controlled trials in a single participant, i.e. where the participant follows the different interventions of the study in a pre-specified or randomized order, and the outcome (e.g. improvement of lower back pain or rheumatoid arthritis pain) is compared between interventions.

Here, we are building a platform called StudyU, developing and evaluating necessary tools and methods for the platform, and applying the platform to derive and evaluate individualized treatment effects. Also, we are working on user-centric N-of-1 trials and have developed the StudyMe tool.

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”. Further development is done in different projects, Master theses, collaborations, and in the ongoing Master project in Summer 2022 "Adaptive digital N-of-1 trials 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.

Details

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

Clinical use cases

  • Ongoing FAB Study: Free of Antidepressiva - clinical support when stopping the use of antidepressive medication through open-label placebo (study homepage, trial registration)

  • Assess the effect of digital physical exercise interventions on chronic unspecific low back pain

  • Assess the short-term and medium-term effect of drinking coffee on heart rate and blood pressure 

Publications

  • 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.

Team:

  • Stefan Konigorski
  • Juliana Schneider
  • Thomas Gärtner
  • Babajide Owoyele
  • Tamara Slosarek
  • Johannes Vedder
  • Janusch Jacoby
  • Pauline Gieseler
  • Sarah Wernicke
  • Alexander Zenner
  • Nils Strelow
  • Fabian Pottbäcker
  • Manisha Manaswini
  • Darius Ruether
  • Florian Henschel
  • Erwin Böttinger

StudyMe App

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.

Details

  • An illustrative video of StudyMe can be found here.

Publications

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.