Hackett Katie L, Campbell Miglena, Pakpahan Eduwin, Vines John, Lendrem Dennis, McCready Jemma, Rapley Tim, Ellis Jason, Deary Vincent, McColl Elaine, McCallum Claire
Department of Social Work, Education and Community Wellbeing, Northumbria University, Newcastle upon Tyne, United Kingdom.
Institute for Collective Place Leadership, Teesside University, Middlesbrough, United Kingdom.
Front Digit Health. 2025 Jun 3;7:1549093. doi: 10.3389/fdgth.2025.1549093. eCollection 2025.
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.
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 ( = 318) or control-version ( = 299). In-app randomisation produced balanced groups. In week 1 engagement was higher in the intervention group = 4.76 logins (S.D. 8.06) than the control group = 3.47 (S.D. 2.75). At week 2 engagement dropped in both groups (intervention group = 1.17, SD 4.56, control = 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.
对一款针对干燥综合征（SjD）患者的新型智能手机自我管理应用程序进行全面远程有效性评估的试点并评估其可行性，包括评估试验程序和应用程序参与度。
我们对一款包含交互式组件的自我管理智能手机应用程序（Sjogo）与仅提供信息的对照应用程序进行了双盲、随机、完全远程的试点可行性研究。完成入职程序后，参与者从苹果应用商店和谷歌应用商店下载应用程序后被分配到试验组。参与者在基线时以及下载后另外两个时间点（5 - 7周和10 - 13周）完成症状和生活质量测量。通过登录次数和登录时长来衡量对应用程序的参与度。
996名参与者将Sjogo下载到他们的智能手机上。871名（87.45%）同意参与研究，617名（61.95%）完成了入职程序和基线测量，并被随机分配到应用程序的完整版（n = 318）或对照版（n = 299）。应用程序内随机分组产生了平衡的组。在第1周，干预组的参与度更高（平均登录次数 = 4.76，标准差8.06），高于对照组（平均登录次数 = 3.47，标准差2.75）。在第2周，两组的参与度均下降（干预组 = 1.17，标准差4.56，对照组 = 0.40，标准差0.93）。后续时间点的结果完成率分别为36.63%（5 - 7周）和27.39%（10 - 13周）。
通过应用商店对SjD患者的自我管理智能手机应用程序进行随机对照试验，完全远程收集数据、自动化试验程序并招募参与者是可行的。然而，应用程序参与度和结果完成率有待提高。
