{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T11:05:18Z","timestamp":1761563118867,"version":"3.41.2"},"reference-count":51,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,6,3]],"date-time":"2025-06-03T00:00:00Z","timestamp":1748908800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Digit. Health"],"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>To pilot and assess the feasibility of a fully remote effectiveness evaluation of a novel smartphone self-management app for people living with Sj\u00f6gren disease (SjD), including evaluating trial procedures and app engagement.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>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\u20137 and 10\u201313 weeks) after download. Engagement with the app was measured with number and duration of logins.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>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 (<jats:italic>n<\/jats:italic>\u2009=\u2009318) or control-version (<jats:italic>n<\/jats:italic>\u2009=\u2009299). In-app randomisation produced balanced groups. In week 1 engagement was higher in the intervention group <jats:italic>m<\/jats:italic>\u2009=\u20094.76 logins (S.D. 8.06) than the control group <jats:italic>m<\/jats:italic>\u2009=\u20093.47 (S.D. 2.75). At week 2 engagement dropped in both groups (intervention group <jats:italic>m<\/jats:italic>\u2009=\u20091.17, SD 4.56, control <jats:italic>m<\/jats:italic>\u2009=\u20090.40, SD 0.93). Outcome completion rates at subsequent timepoints were 36.63% (weeks 5\u20137) and 27.39% (weeks 10\u201313).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fdgth.2025.1549093","type":"journal-article","created":{"date-parts":[[2025,6,3]],"date-time":"2025-06-03T05:23:47Z","timestamp":1748928227000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["A pragmatic double blind remote pilot feasibility randomised controlled trial of a self-management app for people with Sj\u00f6gren disease"],"prefix":"10.3389","volume":"7","author":[{"given":"Katie L.","family":"Hackett","sequence":"first","affiliation":[]},{"given":"Miglena","family":"Campbell","sequence":"additional","affiliation":[]},{"given":"Eduwin","family":"Pakpahan","sequence":"additional","affiliation":[]},{"given":"John","family":"Vines","sequence":"additional","affiliation":[]},{"given":"Dennis","family":"Lendrem","sequence":"additional","affiliation":[]},{"given":"Jemma","family":"McCready","sequence":"additional","affiliation":[]},{"given":"Tim","family":"Rapley","sequence":"additional","affiliation":[]},{"given":"Jason","family":"Ellis","sequence":"additional","affiliation":[]},{"given":"Vincent","family":"Deary","sequence":"additional","affiliation":[]},{"given":"Elaine","family":"McColl","sequence":"additional","affiliation":[]},{"given":"Claire","family":"McCallum","sequence":"additional","affiliation":[]}],"member":"1965","published-online":{"date-parts":[[2025,6,3]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"1","DOI":"10.12688\/f1000research.8352.1","article-title":"Recent advances in primary Sjogren\u2019s syndrome","volume":"5","author":"Holdgate","year":"2016","journal-title":"F1000Res"},{"key":"B2","doi-asserted-by":"publisher","first-page":"1983","DOI":"10.1136\/annrheumdis-2014-205375","article-title":"Epidemiology of primary Sjogren\u2019s syndrome: a systematic review and meta-analysis","volume":"74","author":"Qin","year":"2015","journal-title":"Ann Rheum Dis"},{"key":"B3","doi-asserted-by":"publisher","first-page":"97","DOI":"10.1056\/NEJMcp1702514","article-title":"Primary Sjogren\u2019s syndrome","volume":"379","author":"Mariette","year":"2018","journal-title":"N Engl J Med"},{"key":"B4","doi-asserted-by":"publisher","first-page":"409","DOI":"10.1093\/rheumatology\/keae152","article-title":"British Society for rheumatology guideline on management of adult and juvenile onset Sj\u00f6gren disease","volume":"64","author":"Price","year":"2025","journal-title":"Rheumatology"},{"key":"B5","doi-asserted-by":"publisher","first-page":"1537","DOI":"10.3390\/jcm13061537","article-title":"The physical and psychosocial impact of fatigue among patients with Sjogren\u2019s syndrome: a systematic review","volume":"13","author":"Mardale","year":"2024","journal-title":"J Clin Med"},{"key":"B6","doi-asserted-by":"publisher","first-page":"105502","DOI":"10.1016\/j.jbspin.2022.105502","article-title":"Non-primary Sjogren\u2019s syndrome: secondary or associated?","volume":"90","author":"Felten","year":"2023","journal-title":"Joint Bone Spine"},{"key":"B7","doi-asserted-by":"publisher","first-page":"4065","DOI":"10.1093\/rheumatology\/keac053","article-title":"Activity interference in patients with Sj\u00f6gren\u2019s syndrome: a cross-sectional study of 149 patients in the UK","volume":"61","author":"Schoon","year":"2022","journal-title":"Rheumatology"},{"key":"B8","doi-asserted-by":"publisher","first-page":"2066","DOI":"10.1093\/rheumatology\/kez142","article-title":"Treatment of Sj\u00f6gren\u2019s syndrome: current therapy and future directions","volume":"60","author":"Fox","year":"2021","journal-title":"Rheumatology (Oxford)"},{"key":"B9","doi-asserted-by":"publisher","first-page":"2025","DOI":"10.1093\/rheumatology\/kev227","article-title":"A systematic review of non-pharmacological interventions for primary Sjogren\u2019s syndrome","volume":"54","author":"Hackett","year":"2015","journal-title":"Rheumatology (Oxford)"},{"key":"B10","doi-asserted-by":"publisher","first-page":"1064","DOI":"10.1002\/acr.23536","article-title":"Mixed-methods study identifying key intervention targets to improve participation in daily living activities in primary Sjogren\u2019s syndrome patients","volume":"70","author":"Hackett","year":"2018","journal-title":"Arthritis Care Res (Hoboken)"},{"key":"B11","doi-asserted-by":"publisher","first-page":"218","DOI":"10.1177\/0308022617745006","article-title":"Experience of sleep disruption in primary Sjogren\u2019s syndrome: a focus group study","volume":"81","author":"Hackett","year":"2018","journal-title":"Br J Occup Ther"},{"article-title":"Developing a non-pharmacological intervention model to improve function and participation in people with primary Sj\u00f6gren\u2019s syndrome. 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