Top

Published in:

Open Access 01-12-2022 | Methodology

StudyMe: a new mobile app for user-centric N-of-1 trials

Authors: Alexander M. Zenner, Erwin Böttinger, Stefan Konigorski

Published in: Trials | Issue 1/2022

Abstract

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, there is a gap in supporting non-experts in conducting their own user-centric trials. In this study, we present StudyMe, an open-source mobile application that is freely available from https://play.google.com/store/apps/details?id=health.studyu.me and offers users flexibility and guidance in configuring every component of their trials. We also present research that informed the development of StudyMe, focusing on trial creation. 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.

Available only for authorised users

Neuringer A. Self-experimentation: A call for change. Behaviorism. 1981;9(1):79–94.

Wolf GI, De Groot M. A conceptual framework for personal science. Front Comp Sci. 2020;2(21).

Guyatt G, Sackett D, Taylor DW, Ghong J, Roberts R, Pugsley S. Determining optimal therapy — randomized trials in individual patients. N Engl J Med. 1986;314(14):889–92.CrossRef

Lillie EO, Patay B, Diamant J, Issell B, Topol EJ, Schork NJ. The n-of-1 clinical trial: The ultimate strategy for individualizing medicine? Pers Med. 2011;8(2):161–73.CrossRef

Tate RL, Perdices M. N-of-1 trials in the behavioral sciences. In: Nikles J, Mitchell G, editors. The Essential Guide to N-of-1 Trials in Health. Dordrecht: Springer Netherlands; 2015. p. 19–41.CrossRef

Deering S, Pratap A, Suver C, Borelli AJ, Amdur A, Headapohl W, et al. Real-world longitudinal data collected from the SleepHealth mobile app study. Scientific Data. 2020;7(418).

Bot BM, Suver C, Neto EC, Kellen M, Klein A, Bare C, et al. The mPower study, Parkinson disease mobile data collected using ResearchKit. Scientific Data. 2016;3(160011).

Konigorski S, Wernicke S, Slosarek T, Zenner AM, Strelow N, Ruether DF, Henschel F, Manaswini M, Pottbäcker F, Edelman JA, Owoyele B, Danieletto M, Golden E, Zweig M, Nadkarni GN, Böttinger E. StudyU: A Platform for Designing and Conducting Innovative Digital N-of-1 Trials. J Med Internet Res. 2022 Jul 5;24(7):e35884. https://doi.org/10.2196/35884.

Golden E, Johnson M, Jones M, Viglizzo R, Bobe J, Zimmerman N. Measuring the effects of caffeine and L-theanine on cognitive performance: A protocol for self-directed, mobile N-of-1 studies. Front Comp Sci. 2020;2(4).

10.

Daskalova N, Metaxa-Kakavouli D, Tran A, Nugent N, Boergers J, McGeary J, et al. SleepCoacher: A personalized automated self- experimentation system for sleep recommendations. In: Proceedings of the Annual Symposium on User Interface Software and Technology, Tokyo, Japan: ACM; 2016. p. 347–58.CrossRef

11.

Barr C, Marois M, Sim I, Schmid CH, Wilsey B, Ward D, et al. The PREEMPT study - evaluating smartphone-assisted n-of-1 trials in patients with chronic pain: Study protocol for a randomized controlled trial. Trials. 2015;16(67).

12.

Karkar R, Schroeder J, Epstein DA, Pina LR, Scofield J, Fogarty J, et al. TummyTrials: A feasibility study of using self-experimentation to detect individualized food triggers. In: Proceedings of the CHI Conference on Human Factors in Computing Systems, Denver, CO, USA: ACM; 2017. p. 6850–63.

13.

Taylor S, Sano A, Ferguson C, Mohan A, Picard RW. QuantifyMe: An open-source automated single-case experimental design platform. Sensors. 2018;18(4):1097.

14.

Kravitz R, Duan N, Eslick I, Gabler NB, Kaplan HC, Larson EB, et al. Design and Implementation of N-of-1 Trials: A User’s Guide. Rockville: Agency for Healthcare Research and Quality; 2014. Available from: https://effectivehealthcare.ahrq.gov/products/n-1-trials/research-2014-5

15.

Carriere KC, Li Y, Mitchell G, Senior H. Methodological considerations for N-of-1 trials. In: Nikles J, Mitchell G, editors. The Essential Guide to N-of-1 Trials in Health. Dordrecht: Springer Netherlands; 2015. p. 67–80.CrossRef

16.

Braun V, Clarke C. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101.CrossRef

17.

Locke EA, Latham GP. A Theory of Goal Setting & Task Performance. Englewood Cliffs: Prentice Hall; 1990.

18.

Brooke J. SUS: A ‘quick and dirty’ usability scale. In: Jordan PW, Thomas B, Weerdmeester BA, McClelland IL, editors. Usability Evaluation in Industry. London: Taylor & Francis; 1996. p. 189–94.

19.

Sauro J, Lewis JR. Quantifying the User Experience: Practical Statistics for User Research. Waltham: Elsevier/Morgan Kaufmann; 2012.

20.

Daskalova N, Kyi E, Ouyang K, Borem A, Chen S, Park SH, Nugent N, Huang J. Self-E: Smartphone- Supported Guidance for Customizable Self-Experimentation. In: Proceedings of the 2021 CHI Conference on Human Factors in Computing Systems. Association for Computing Machinery, New York, NY, USA. ACM; 2021, Article 227, p. 1-13.

21.

Yoon S, Schwartz JE, Burg MM, Kronish IM, Alcantara C, Julian J, et al. Using Behavioral Analytics to Increase Exercise: A Randomized N-of-1 Study. Am J Prev Med. 2018;54(4):559–67.CrossRef

22.

Brannon EE, Cushing CC, Walters RW, Crick C, Noser AE, Mullins LL. Goal feedback from whom? A physical activity intervention using an N-of-1 RCT. Psychol Health. 2017;33(6):701–12.CrossRef

23.

Kaplan HC, Opipari-Arrigan L, Schmid CH, Schuler CL, Saeed S, Braly KL, et al. Evaluating the comparative effectiveness of two diets in pediatric inflammatory bowel disease: A study protocol for a series of N-of-1 trials. Healthcare. 2019;7(4):129.

24.

Guyatt G, Sackett D, Adachi J, Roberts R, Chong J, Rosenbloom C, et al. A clinician’s guide for conducting randomized trials in individual patients. Can Med Assoc J. 1988;139(6):497–503.

25.

Boutron I, Tubach F, Giraudeau B, Ravaud P. Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials. J Clin Epidemiol. 2004;57(6):543–50.CrossRef

26.

Johnson D, Deterding S, Kuhn KA, Staneva A, Stoyanov S, Hides L. Gamification for health and wellbeing: A systematic review of the literature. Internet Interv. 2016;6:89–106.CrossRef

Title: StudyMe: a new mobile app for user-centric N-of-1 trials
Authors: Alexander M. Zenner
Erwin Böttinger
Stefan Konigorski
Publication date: 01-12-2022
Publisher: BioMed Central
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06893-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

StudyMe: a new mobile app for user-centric N-of-1 trials

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Please log in to get access to this content

Other articles of this Issue 1/2022

Open hemorrhoidectomy under local anesthesia versus saddle block in western Uganda: a study protocol for a prospective equivalence randomized, double-blind controlled trial

The effectiveness and cost-effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) for trauma patients with uncontrolled torso haemorrhage: study protocol for a randomised clinical trial (the UK-REBOA trial)

Implementation and evaluation of a large-scale postpartum family planning program in Rwanda: study protocol for a clinic-randomized controlled trial

A cross-sectional survey on the early impact of COVID-19 on the uptake of decentralised trial methods in the conduct of clinical trials

Effects of Jianpi Lishi Jiedu granules on colorectal adenoma patients after endoscopic treatment: study protocol for a randomized, double-blinded, placebo-controlled clinical trial

Protocol for a randomised controlled trial to investigate the effects of vitamin K2 on recovery from muscle-damaging resistance exercise in young and older adults—the TAKEOVER study