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首页> 外文期刊>Journal of medical Internet research >A Web-Based Telemanagement System for Improving Disease Activity and Quality of Life in Patients With Complex Inflammatory Bowel Disease: Pilot Randomized Controlled Trial
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A Web-Based Telemanagement System for Improving Disease Activity and Quality of Life in Patients With Complex Inflammatory Bowel Disease: Pilot Randomized Controlled Trial

机译：基于Web的远程管理系统，可改善复杂性炎症性肠病患者的疾病活动性和生活质量：随机对照试验

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BackgroundThe reported efficacy of telemedicine in patients with inflammatory bowel disease (IBD) is inconsistent among studies, and data for complex IBD are lacking.ObjectiveWe aimed to evaluate the impact of remote monitoring using a Web system— Telemonitorización de la Enfermedad de Crohn y Colitis Ulcerosa or Telemonitoring of Crohn’s Disease and Ulcerative Colitis (TECCU)—as compared to standard care and telephone care on health outcomes and health care in patients with complex IBD.MethodsWe performed a 3-arm randomized controlled trial. Adult patients with IBD who received immunosuppressants and biological agents were recruited from the IBD Unit of a tertiary university hospital. The patients were randomized into groups to receive remote monitoring (G_TECCU), nurse-assisted telephone care (G_NT), or standard care with in-person visits (G_control). All patients completed the study visits at baseline and at 12 and 24 weeks in addition to each type of intervention. The primary outcome was the percentage of patients in remission at 24 weeks. Secondary health outcomes were quality of life, medication adherence, adverse effects, satisfaction, and social activities. Data on the number of outpatient visits and telephone calls, emergency visits, hospitalizations, IBD-related surgeries, and corticosteroid courses were also collected.ResultsA total of 63 patients were selected (21 patients in each group). During the study, 90.5% (19/21) of patients in G_control, 95.2% (20/21) in G_NT, and 85.7% (18/21) in G_TECCU were compliant to the intervention. After 24 weeks, the percentage of patients in remission was higher in G_TECCU (17/21, 81%) than in G_NT (14/21, 66.7%) and G_control (15/21, 71.4%). A higher improvement in disease activity was observed in G_TECCU than in G_control in terms of the Harvey-Bradshaw/Mayo (odds ratio=0.12, 95% CI=0.003-2.162, P =.19) and Harvey-Bradshaw/Walmsley (odds ratio=0.11, 95% CI=0.004-1.55, P =.13) indexes. Improvement in disease activity was associated with a larger reduction in fecal calprotectin values in G_TECCU compared to G_control (estimated intervention effect: odds ratio=–0.90; 95% CI=–1.96 to 0.16, P =.11). All completers adhered to treatment in G_TECCU. In addition, the quality of life, social activities, and satisfaction improved in all 3 groups. Although the number of outpatient visits and telephone calls was lower in G_TECCU than in G_NT and G_control, the safety profile was similar in all 3 groups.ConclusionsThis pilot clinical trial suggests that the TECCU Web-based system is a safe strategy for improving health outcomes in patients with complex IBD and reducing the use of health care resources.Trial RegistrationClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT02943538","term_id":"NCT02943538"}}NCT02943538; https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT02943538","term_id":"NCT02943538"}}NCT02943538 (Archived by WebCite at http://www.webcitation.org/746CRRtDN).
机译：背景研究报道的远程医疗在炎症性肠病（IBD）患者中的疗效不一致，并且缺乏复杂IBD的数据。目的我们旨在评估使用Web系统远程监控的影响-Telemonitorizaciónde la Enfermedad de Crohn y Colitis Ulcerosa或克罗恩氏病和溃疡性结肠炎（TECCU）的远程监控-与标准护理和电话护理相比，复杂IBD患者的健康结局和健康护理。方法我们进行了3组随机对照试验。从一家三级大学医院的IBD部门招募了接受免疫抑制剂和生物制剂治疗的IBD成年患者。将患者随机分组，接受远程监控（G_TECCU），护士协助的电话护理（G_NT）或亲自就诊的标准护理（G_control）。除每种干预措施外，所有患者均在基线以及第12和24周完成研究访问。主要结局是24周缓解的患者百分比。次要健康状况是生活质量，药物依从性，不良反应，满意度和社交活动。还收集了有关门诊和电话，急诊，住院，IBD相关手术和糖皮质激素疗程的数据。结果共入选63例患者（每组21例）。在研究期间，G_control的患者中有90.5％（19/21），G_NT的患者有95.2％（20/21），G_TECCU的患者有85.7％（18/21）符合干预措施。 24周后，G_TECCU（17/21，81％）的缓解率高于G_NT（14/21，66.7％）和G_control（15/21，71.4％）。就Harvey-Bradshaw / Mayo（奇数比= 0.12，95％CI = 0.003-2.162，P = .19）和Harvey-Bradshaw / Walmsley（奇数比）而言，在G_TECCU中观察到的疾病活动性比在G_control中更高。 = 0.11，95％CI = 0.004-1.55，P = .13）。与G_control相比，疾病活动性的改善与G_TECCU中粪便钙卫蛋白值的降低幅度更大有关（估计干预效果：优势比= –0.90; 95％CI = –1.96至0.16，P = .11）。所有完成者都坚持使用G_TECCU处理。此外，所有三个组的生活质量，社交活动和满意度都有所提高。尽管G_TECCU的门诊就诊次数和电话呼叫次数均低于G_NT和G_control，但所有三个组的安全性均相似。结论这项临床试验表明，基于TECCU的Web系统是改善患者健康状况的安全策略。 IBD复杂的患者，减少了对医疗保健资源的使用。TrialRegistrationClinicalTrials.gov {“ type”：“ clinical-trial”，“ attrs”：{“ text”：“ NCT02943538”，“ term_id”：“ NCT02943538”}} NCT02943538; https://clinicaltrials.gov/ct2/show/ {“ type”：“ clinical-trial”，“ attrs”：{“ text”：“ NCT02943538”，“ term_id”：“ NCT02943538”}} NCT02943538（由WebCite存档在http://www.webcitation.org/746CRRtDN）。

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