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

Lookup NU author(s): Dr Katie Hackett, Dr Eduwin PakpahanORCiD, Dr Dennis Lendrem, Professor Tim Rapley, Professor Jason Ellis, Vincent Deary, Emerita Professor Elaine McCollORCiD

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Licence

This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

2025 Hackett, Campbell, Pakpahan, Vines, Lendrem, McCready, Rapley, Ellis, Deary, McColl and McCallum. Objectives: 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. Methods: 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). Conclusion: 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.


Publication metadata

Author(s): Hackett KL, Campbell M, Pakpahan E, Vines J, Lendrem D, McCready J, Rapley T, Ellis J, Deary V, McColl E, McCallum C

Publication type: Article

Publication status: Published

Journal: Frontiers in Digital Health

Year: 2025

Volume: 7

Online publication date: 03/06/2025

Acceptance date: 19/05/2025

Date deposited: 30/06/2025

ISSN (electronic): 2673-253X

Publisher: Frontiers Media SA

URL: https://doi.org/10.3389/fdgth.2025.1549093

DOI: 10.3389/fdgth.2025.1549093

Data Access Statement: The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.


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Funding

Funder referenceFunder name
Versus Arthritis (ref: 22026)

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