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

Abstract

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.