Michaël Doumen, Elias De Meyst, Delphine Bertrand, Sofia Pazmino, Marine Piessens, Johan Joly, Mieke Devinck, René Westhovens, Patrick Verschueren
{"title":"支持类风湿关节炎患者自我管理和远程监控疾病影响的手机应用:随机对照 AEGORA 试验。","authors":"Michaël Doumen, Elias De Meyst, Delphine Bertrand, Sofia Pazmino, Marine Piessens, Johan Joly, Mieke Devinck, René Westhovens, Patrick Verschueren","doi":"10.1093/rheumatology/keae638","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>We aimed to study if smartphone applications could support the self-management of RA, while investigating engagement and potential negative psychological effects with app-use.</p><p><strong>Methods: </strong>App-based Education and GOal-setting in RA (AEGORA) was a multicentre randomised controlled trial with 2:1:1-allocation to usual care or two versions of an app-based self-management intervention for RA. The 16-week programme involved patient education, goal-setting, and remote monitoring of the Rheumatoid Arthritis Impact of Disease (RAID) instrument, either weekly or monthly depending on randomisation. The primary end point was improvement in the Arthritis Self-Efficacy Scale (ASES) after 16 weeks. Secondary endpoints included non-inferiority regarding the Pain Catastrophizing Scale (PCS) and superiority regarding patient-reported physical activity, sleep quality and RAID. App engagement and RAID-scores were analysed descriptively.</p><p><strong>Results: </strong>Overall, 122 patients were included: mean (SD) disease duration 12 (9) years, mean (SD) age 58(11), 68% female, mean (SD) DAS28-CRP 2.4(0.9). The intervention did not improve the ASES-score over usual care (β: 0.44, p= 0.87). Non-inferiority was established for the PCS (β -0.95 [95% CI -3.30 to + 1.40] favouring the intervention). Other predefined outcomes did not differ. App retention steadily declined to 43% by 16 weeks. Although the RAID remained stable over time overall, 35% of app users reported ≥1 episode of clinically relevant worsening over 16 weeks.</p><p><strong>Conclusion: </strong>This app-based self-management intervention was not superior to usual care regarding self-efficacy improvement. However, remote symptom monitoring provided valuable insight and did not increase pain catastrophising, alleviating concerns regarding the psychological impact of remote monitoring with apps.</p><p><strong>Trial registration number: </strong>clinicaltrials.gov, NCT05888181.</p>","PeriodicalId":21255,"journal":{"name":"Rheumatology","volume":" ","pages":""},"PeriodicalIF":4.7000,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A mobile app to support self-management and remotely monitor disease impact in rheumatoid arthritis: the randomised controlled AEGORA trial.\",\"authors\":\"Michaël Doumen, Elias De Meyst, Delphine Bertrand, Sofia Pazmino, Marine Piessens, Johan Joly, Mieke Devinck, René Westhovens, Patrick Verschueren\",\"doi\":\"10.1093/rheumatology/keae638\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>We aimed to study if smartphone applications could support the self-management of RA, while investigating engagement and potential negative psychological effects with app-use.</p><p><strong>Methods: </strong>App-based Education and GOal-setting in RA (AEGORA) was a multicentre randomised controlled trial with 2:1:1-allocation to usual care or two versions of an app-based self-management intervention for RA. The 16-week programme involved patient education, goal-setting, and remote monitoring of the Rheumatoid Arthritis Impact of Disease (RAID) instrument, either weekly or monthly depending on randomisation. The primary end point was improvement in the Arthritis Self-Efficacy Scale (ASES) after 16 weeks. Secondary endpoints included non-inferiority regarding the Pain Catastrophizing Scale (PCS) and superiority regarding patient-reported physical activity, sleep quality and RAID. App engagement and RAID-scores were analysed descriptively.</p><p><strong>Results: </strong>Overall, 122 patients were included: mean (SD) disease duration 12 (9) years, mean (SD) age 58(11), 68% female, mean (SD) DAS28-CRP 2.4(0.9). The intervention did not improve the ASES-score over usual care (β: 0.44, p= 0.87). Non-inferiority was established for the PCS (β -0.95 [95% CI -3.30 to + 1.40] favouring the intervention). Other predefined outcomes did not differ. App retention steadily declined to 43% by 16 weeks. 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A mobile app to support self-management and remotely monitor disease impact in rheumatoid arthritis: the randomised controlled AEGORA trial.
Objectives: We aimed to study if smartphone applications could support the self-management of RA, while investigating engagement and potential negative psychological effects with app-use.
Methods: App-based Education and GOal-setting in RA (AEGORA) was a multicentre randomised controlled trial with 2:1:1-allocation to usual care or two versions of an app-based self-management intervention for RA. The 16-week programme involved patient education, goal-setting, and remote monitoring of the Rheumatoid Arthritis Impact of Disease (RAID) instrument, either weekly or monthly depending on randomisation. The primary end point was improvement in the Arthritis Self-Efficacy Scale (ASES) after 16 weeks. Secondary endpoints included non-inferiority regarding the Pain Catastrophizing Scale (PCS) and superiority regarding patient-reported physical activity, sleep quality and RAID. App engagement and RAID-scores were analysed descriptively.
Results: Overall, 122 patients were included: mean (SD) disease duration 12 (9) years, mean (SD) age 58(11), 68% female, mean (SD) DAS28-CRP 2.4(0.9). The intervention did not improve the ASES-score over usual care (β: 0.44, p= 0.87). Non-inferiority was established for the PCS (β -0.95 [95% CI -3.30 to + 1.40] favouring the intervention). Other predefined outcomes did not differ. App retention steadily declined to 43% by 16 weeks. Although the RAID remained stable over time overall, 35% of app users reported ≥1 episode of clinically relevant worsening over 16 weeks.
Conclusion: This app-based self-management intervention was not superior to usual care regarding self-efficacy improvement. However, remote symptom monitoring provided valuable insight and did not increase pain catastrophising, alleviating concerns regarding the psychological impact of remote monitoring with apps.
期刊介绍:
Rheumatology strives to support research and discovery by publishing the highest quality original scientific papers with a focus on basic, clinical and translational research. The journal’s subject areas cover a wide range of paediatric and adult rheumatological conditions from an international perspective. It is an official journal of the British Society for Rheumatology, published by Oxford University Press.
Rheumatology publishes original articles, reviews, editorials, guidelines, concise reports, meta-analyses, original case reports, clinical vignettes, letters and matters arising from published material. The journal takes pride in serving the global rheumatology community, with a focus on high societal impact in the form of podcasts, videos and extended social media presence, and utilizing metrics such as Altmetric. Keep up to date by following the journal on Twitter @RheumJnl.