Doumen Michaël, De Meyst Elias, Bertrand Delphine, Pazmino Sofia, Piessens Marine, Joly Johan, Devinck Mieke, Westhovens René, Verschueren Patrick
Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium.
Rheumatology, University Hospitals Leuven, Leuven, Belgium.
Rheumatology (Oxford). 2025 May 1;64(5):2505-2514. doi: 10.1093/rheumatology/keae638.
The aim of this work was to determine whether smartphone applications could support the self-management of RA and to investigate engagement and potential negative psychological effects with app-use.
App-based Education and GOal-setting in RA (AEGORA) was a multicentre randomized 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 randomization. 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.
Overall, 122 patients were included: mean (s.d.) disease duration 12 (9) years, age 58 (11), 68% female, 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, +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.
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 catastrophizing, alleviating concerns regarding the psychological impact of remote monitoring with apps.
clinicaltrials.gov, NCT05888181.
本研究旨在确定智能手机应用程序是否能支持类风湿关节炎（RA）的自我管理，并调查使用应用程序的参与度和潜在的负面心理影响。
基于应用程序的类风湿关节炎教育与目标设定（AEGORA）是一项多中心随机对照试验，按2:1:1的比例分配至常规护理组或两种基于应用程序的RA自我管理干预版本。为期16周的项目包括患者教育、目标设定以及对类风湿关节炎疾病影响（RAID）工具的远程监测，根据随机分组情况，监测频率为每周或每月一次。主要终点是16周后关节炎自我效能量表（ASES）的改善情况。次要终点包括疼痛灾难化量表（PCS）方面的非劣效性，以及患者报告的身体活动、睡眠质量和RAID方面的优越性。对应用程序的参与度和RAID评分进行了描述性分析。
总共纳入了122例患者：平均（标准差）病程12（9）年，年龄58（11）岁，68%为女性，DAS28-CRP为2.4（0.9）。与常规护理相比，干预措施并未改善ASES评分（β = 0.44，P = 0.87）。在PCS方面确立了非劣效性（β = -0.95 [95%置信区间 -3.30, +1.40]，干预组更优）。其他预定义结局无差异。到16周时，应用程序的留存率稳步下降至43%。尽管总体上RAID随时间保持稳定，但35%的应用程序用户报告在16周内出现≥1次具有临床意义的病情恶化。
这种基于应用程序的自我管理干预在改善自我效能方面并不优于常规护理。然而，远程症状监测提供了有价值的见解，且未增加疼痛灾难化，减轻了对应用程序远程监测心理影响的担忧。
clinicaltrials.gov，NCT05888181。
