Department of Dermatology and Allergy Centre, Odense University Hospital, Odense, Denmark.
Centre for Innovative Medical Technology (CIMT), Clinical Institute, University of Southern Denmark, Odense, Denmark.
Br J Dermatol. 2018 Nov;179(5):1062-1071. doi: 10.1111/bjd.16667. Epub 2018 Jul 5.
Adherence to topical psoriasis treatments is low, which leads to unsatisfactory treatment results. Smartphone applications (apps) for patient support exist but their potential to improve adherence has not been systematically evaluated.
To evaluate whether a study-specific app improves adherence and reduces psoriasis symptoms compared with standard treatment.
We conducted a randomized controlled trial (RCT, clinicaltrials.gov registration: NCT02858713). Patients received once-daily medication [calcipotriol/betamethasone dipropionate (Cal/BD) cutaneous foam] and were randomized to no app (n = 66) or app intervention (n = 68) groups. In total, 122 patients (91%) completed the 22-week follow-up. The primary outcome was adherence, which was defined as medication applied ≥ 80% of days during the treatment period and assessed by a chip integrated into the medication dispenser. Secondary outcomes were psoriasis severity measured by the Lattice System Physician's Global Assessment (LS-PGA) and quality of life, measured using the Dermatology Life Quality Index (DLQI) at all visits.
Intention-to-treat analyses using regression was performed. More patients in the intervention group were adherent to Cal/BD cutaneous foam than those in the nonintervention group at week 4 (65% vs. 38%, P = 0·004). The intervention group showed a greater LS-PGA reduction than the nonintervention group at week 4 (mean 1·86 vs. 1·46, P = 0·047). A similar effect was seen at weeks 8 and 26, although it did not reach statistical significance.
This RCT demonstrates that the app improved short-term adherence to Cal/BD cutaneous foam treatment and psoriasis severity.
患者对局部治疗银屑病药物的依从性低，导致治疗效果不理想。目前已经存在一些用于患者支持的智能手机应用程序，但它们改善依从性的潜力尚未得到系统评估。
评估特定于研究的应用程序是否可以提高依从性并减轻银屑病症状，与标准治疗相比。
我们进行了一项随机对照试验（RCT，临床试验.gov 注册号：NCT02858713）。患者接受每日一次的药物治疗[卡泊三醇/倍他米松二丙酸酯（Cal/BD）乳膏]，并随机分为无应用程序（n=66）或应用程序干预（n=68）组。共有 122 名患者（91%）完成了 22 周的随访。主要结局是依从性，定义为治疗期间至少应用药物 80%的天数，通过药物分配器中集成的芯片进行评估。次要结局是使用 Lattice System Physician's Global Assessment（LS-PGA）测量的银屑病严重程度和所有就诊时使用 Dermatology Life Quality Index（DLQI）测量的生活质量。
采用回归进行意向治疗分析。干预组在第 4 周时 Cal/BD 乳膏的依从性高于非干预组（65%比 38%，P=0.004）。与非干预组相比，干预组在第 4 周时 LS-PGA 降低更为明显（平均降低 1.86 比 1.46，P=0.047）。在第 8 周和第 26 周也观察到类似的效果，但没有达到统计学意义。
这项 RCT 表明，该应用程序提高了 Cal/BD 乳膏治疗的短期依从性和银屑病严重程度。
