ORIGINAL RESEARCH article

Front. Digit. Health

Sec. Human Factors and Digital Health

Volume 7 - 2025 | doi: 10.3389/fdgth.2025.1549093

This article is part of the Research TopicDesigning for Engagement in Digital Health for Chronic and Long-Term CareView all 4 articles

A pragmatic double blind remote pilot feasibility randomised controlled trial of a self-management app for people with Sjögren disease

Provisionally accepted
Katie L HackettKatie L Hackett1*Miglena CampbellMiglena Campbell2Eduwin PakpahanEduwin Pakpahan3John VinesJohn Vines4Dennis William LendremDennis William Lendrem5Jemma McCreadyJemma McCready6Jason Gordon EllisJason Gordon Ellis6Tim RapleyTim Rapley1Vincent DearyVincent Deary6Elaine McCollElaine McColl7Claire McCallumClaire McCallum8,9
  • 1Department of Social Work, Education and Community Wellbeing, Northumbria University, Newcastle upon Tyne, England, United Kingdom
  • 2Institute for Collective Place Leadership, Teesside University, Middlesbrough, United Kingdom
  • 3Department of Mathematics, Physics and Electrical Engineering, Northumbria University, Newcastle upon Tyne, United Kingdom
  • 4School of Informatics, University of Edinburgh, Edinburgh, Scotland, United Kingdom
  • 5Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, England, United Kingdom
  • 6Department of Psychology, Northumbria University, Newcastle upon Tyne, North East England, United Kingdom
  • 7Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, England, United Kingdom
  • 8Faculty of Engineering, University of Bristol, Bristol, England, United Kingdom
  • 9Digital Health Validation Lab, Glasgow, United Kingdom

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To pilot and assess the feasibility of a fully remote effectiveness evaluation of a novel smartphone self-management app for people living with Sjögren disease (SjD), including evaluating trial procedures and app engagement.We conducted a double-blind, randomised, fully-remote pilot feasibility of a self-management smartphone app (Sjogo) containing interactive components with an information-only control app. After completing onboarding procedures, participants were allocated to a trial arm following download from Apple App and Google Play stores. Participants completed symptoms and quality of life measures at baseline and (at two further timepoints (5-7 and 10-13 weeks) after download. Engagement with the app was measured with number and duration of logins.Results 996 participants downloaded Sjogo to their smartphone. 871 (87.45%) consented to take part in the study and 617 (61.95%) completed the onboarding procedures and baseline measures and were randomised to the full-version of the app (n=318) or control-version (n=299). In-app randomisation produced balanced groups. In week 1 engagement was higher in the intervention group m=4.76 logins (S.D. 8.06) than the control group m=3.47 (S.D. 2.75). At week 2 engagement dropped in both groups (intervention group m=1.17, SD 4.56, control m=0.40, SD 0.93). Outcome completion rates at subsequent timepoints were 36.63% (weeks 5-7) and 27.39% (weeks 10-13).It is feasible to collect data fully remotely, automate trial procedures, and recruit participants to a randomised controlled trial of a self-management smartphone app for people with SjD through app stores. However, app engagement and outcome completion rates could be improved.

Keywords: Sjögren's syndrome, Sjögren disease, smartphone app, feasibility, Selfmanagement, tools

Received: 20 Dec 2024; Accepted: 19 May 2025.

Copyright: © 2025 Hackett, Campbell, Pakpahan, Vines, Lendrem, McCready, Ellis, Rapley, Deary, McColl and McCallum. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Katie L Hackett, Department of Social Work, Education and Community Wellbeing, Northumbria University, Newcastle upon Tyne, NE1 8ST, England, United Kingdom

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

Supplementary Material