一种用于复杂性炎症性肠病患者的基于网络的远程管理系统：一项随机对照临床试验方案
A Web-Based Telemanagement System for Patients With Complex Inflammatory Bowel Disease: Protocol for a Randomized Controlled Clinical Trial.
作者信息
Aguas Mariam, Del Hoyo Javier, Faubel Raquel, Muñoz Diana, Domínguez David, Bastida Guillermo, Navarro Belén, Barrios Alejandra, Valdivieso Bernardo, Correcher Marisa, Nos Pilar
机构信息
Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, Spain.
CIBEREHD (Networked Biomedical Research Center for Hepatic and Digestive Diseases), Valencia, Spain.
出版信息
JMIR Res Protoc. 2018 Dec 21;7(12):e190. doi: 10.2196/resprot.9639.
BACKGROUND
Telemedicine has been successfully used to provide inflammatory bowel disease (IBD) patients with health care services remotely via the implementation of information and communications technology, which uses safe and feasible apps that have been well accepted by patients in remission. However, the design of telemedicine apps in this setting involves difficulties that hinder the adherence of patients to the follow-up plans and the efficacy of these systems to improve disease activity and quality of life.
OBJECTIVE
This study aimed to evaluate the development of a Web platform, Telemonitoring of Crohn Disease and Ulcerative Colitis (TECCU), for remote monitoring of patients with complex IBD and the design of a clinical trial involving IBD patients who received standard care (G_Control), nurse-assisted telephone care (G_NT), or care based on distance monitoring (G_TECCU).
METHODS
We describe the development of a remote monitoring system and the difficulties encountered in designing the platform. A 3-arm randomized controlled trial was designed to evaluate the effectiveness of this Web platform in disease management compared with G_NT and G_Control.
RESULTS
According to the schedules established for the medical treatment initiated (corticosteroids, immunosuppressants, or biological agents), a total of 63 patients (21 patients from each group) answered periodic questionnaires regarding disease activity, quality of life, therapeutic adherence, adverse effects, satisfaction, work productivity, and social activities. Blood and stool analyses (fecal calprotectin) were performed periodically. On the basis of the results of these tests in G_TECCU, alerts were generated in a Web platform with adapted action plans, including changes in medication and frequency of follow-up. The main issues found were the development of an easy-to-use Web platform, the selection of validated clinical scores and objective biomarkers for remote monitoring, and the design of a clinical trial to compare the 3 main follow-up methods evaluated to date in IBD.
CONCLUSIONS
The development of a Web-based remote management program for safe and adequate control of IBD proved challenging. The results of this clinical trial will advance knowledge regarding the effectiveness of TECCU Web platform for improvement of disease activity, quality of life, and use of health care resources in complex IBD patients.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02943538; https://clinicaltrials.gov/ct2/show/NCT02943538 (Archived by WebCite at http://www.webcitation.org/6y4DQdmt8).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/9639.
背景
通过实施信息通信技术，远程医疗已成功用于为炎症性肠病（IBD）患者远程提供医疗保健服务，该技术使用安全可行且已被缓解期患者广泛接受的应用程序。然而，这种情况下远程医疗应用程序的设计存在困难，阻碍了患者坚持后续计划以及这些系统改善疾病活动和生活质量的效果。
目的
本研究旨在评估一个网络平台——克罗恩病和溃疡性结肠炎远程监测（TECCU）的开发，用于对复杂IBD患者进行远程监测，并设计一项涉及接受标准护理（G_Control）、护士辅助电话护理（G_NT）或基于远程监测的护理（G_TECCU）的IBD患者的临床试验。
方法
我们描述了远程监测系统的开发以及设计该平台时遇到的困难。设计了一项三臂随机对照试验，以评估该网络平台与G_NT和G_Control相比在疾病管理中的有效性。
结果
根据开始的医疗治疗方案（皮质类固醇、免疫抑制剂或生物制剂），共有63名患者（每组21名患者）回答了关于疾病活动、生活质量、治疗依从性、不良反应、满意度、工作效率和社交活动的定期问卷。定期进行血液和粪便分析（粪便钙卫蛋白）。根据G_TECCU中这些测试的结果，在一个具有适应性行动计划的网络平台上生成警报，包括药物调整和随访频率。发现的主要问题是开发一个易于使用的网络平台、选择用于远程监测的经过验证的临床评分和客观生物标志物，以及设计一项临床试验以比较IBD中迄今为止评估的三种主要随访方法。
结论
事实证明，开发一个用于安全、充分控制IBD的基于网络的远程管理程序具有挑战性。这项临床试验的结果将推进关于TECCU网络平台在改善复杂IBD患者的疾病活动、生活质量和医疗资源利用方面有效性的知识。
试验注册
ClinicalTrials.gov NCT02943538；https://clinicaltrials.gov/ct2/show/NCT02943538（由WebCite存档于http://www.webcitation.org/6y4DQdmt8）。
国际注册报告识别码（IRRID）：RR1-10.2196/9639。
Zotero 插件