Department of Respiratory Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.
Department of Respiratory Medicine, Zuyderland Medical, Heerlen, the Netherlands.
Am J Respir Crit Care Med. 2020 Aug 1;202(3):393-401. doi: 10.1164/rccm.202002-0328OC.
Idiopathic pulmonary fibrosis (IPF) is a deadly disease with increasingly impaired health-related quality of life (HRQOL). eHealth technologies facilitate collection of physiological outcomes and patient-reported outcomes at home, but randomized controlled trials (RCTs) on the effects of eHealth are scarce. To investigate whether a home monitoring program improves HRQOL and medication use for patients with IPF. We performed a multicenter RCT in newly treated patients with IPF. Patients were randomly assigned to standard care or a home monitoring program on top of standard care for 24 weeks. The home monitoring program included home spirometry, reporting of symptoms and side effects, patient-reported outcomes, information, a medication coach, and eConsultations. The primary endpoint was between-group difference in change in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) score at 24 weeks. A total of 90 patients were randomized (46 assigned to the home monitoring group and 44 to the standard care group). After 24 weeks, no statistically significant difference was found in K-BILD total score, with a 2.70-point increase in the home monitoring group (SD = 9.5) and a 0.03-point increase in the standard care group (SD = 10.4); between-group difference was 2.67 points (95% confidence interval [CI], -1.85 to 7.17; = 0.24). Between-group difference in psychological domain score was 5.6 points (95% CI, -1.13 to 12.3; = 0.10), with an increase of 5.12 points in the home monitoring group (SD = 15.8) and a decline of 0.48 points in the standard care group (SD = 13.3). In the home monitoring group, medication was more often adjusted (1 vs. 0.3 adjustments per patient; 95% CI, 0.2 to 1.3; = 0.027). Patient satisfaction with the home monitoring program was high. Home-based spirometry was highly correlated with hospital-based spirometry over time. The results of this first-ever eHealth RCT in IPF showed that a comprehensive home monitoring program did not improve overall HRQOL measured with K-BILD but tended to improve psychological well-being. Home monitoring was greatly appreciated by patients and allowed for individually tailored medication adjustments.Clinical trial registered with www.clinicaltrials.gov (NCT03420235).
特发性肺纤维化 (IPF) 是一种致命疾病,患者的健康相关生活质量 (HRQOL) 日益受损。电子健康技术有助于在家中收集生理结果和患者报告的结果,但关于电子健康影响的随机对照试验 (RCT) 却很少。本研究旨在探究家庭监测计划是否能改善 IPF 患者的 HRQOL 和药物使用情况。
我们在新确诊的 IPF 患者中开展了一项多中心 RCT。患者被随机分配至标准护理组或标准护理加家庭监测组,接受为期 24 周的治疗。家庭监测计划包括家庭肺功能检查、症状和副作用报告、患者报告的结果、信息、药物教练和电子咨询。主要终点为 24 周时 King's 简要间质性肺病问卷 (K-BILD) 评分的组间变化差异。
共有 90 名患者被随机分配(家庭监测组 46 名,标准护理组 44 名)。24 周后,家庭监测组 K-BILD 总分增加了 2.70 分(标准差 [SD] = 9.5),标准护理组增加了 0.03 分(SD = 10.4),组间差异为 2.67 分(95%置信区间 [CI],-1.85 至 7.17; = 0.24)。心理领域评分的组间差异为 5.6 分(95% CI,-1.13 至 12.3; = 0.10),家庭监测组增加了 5.12 分(SD = 15.8),标准护理组降低了 0.48 分(SD = 13.3)。在家庭监测组中,药物调整更为频繁(每位患者调整 1 次 vs. 0.3 次;95% CI,0.2 至 1.3; = 0.027)。患者对家庭监测计划的满意度很高。家庭肺功能检查与医院肺功能检查随时间的相关性很高。
这项针对 IPF 的首个电子健康 RCT 结果显示,全面的家庭监测计划并未改善 K-BILD 测量的整体 HRQOL,但可能改善了心理健康。家庭监测深受患者欢迎,并能够进行个体化的药物调整。该研究已在 www.clinicaltrials.gov 注册(NCT03420235)。