Rationale and design of WEBCARE: a randomized, controlled, web-based behavioral intervention trial in cardioverter-defibrillator patients to reduce anxiety and device concerns and enhance quality of life.
Rationale and design of WEBCARE: a randomized, controlled, web-based behavioral intervention trial in cardioverter-defibrillator patients to reduce anxiety and device concerns and enhance quality of life.
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DOI：
10.1186/1745-6215-10-120
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发表时间：
2009-12-23
期刊：
影响因子：
2.5
通讯作者：
van den Broek KC
中科院分区：
文献类型：
--
作者：
Pedersen SS;Spek V;Theuns DA;Alings M;van der Voort P;Jordaens L;Cuijpers P;Denollet J;van den Broek KC
植入式心律转复除颤器（ICD）通常被广泛接受，但25-33%的患者在植入后出现临床水平的焦虑、抑郁和生活质量（QoL）受损。在ICD患者中进行的试验很少调查行为干预是否可以减轻这些适应问题的发展。我们介绍了植入式心脏复律除颤器患者基于WEB的痛苦管理程序（WEBCARE）试验的原理和研究设计。WEBCARE是一项多中心、多学科、随机、对照的行为干预试验，旨在检查基于网络的方法在降低焦虑水平和器械担忧以及提高QoL方面的有效性。住院植入ICD的连续性患者将在住院期间参与研究，并在基线（植入后5-10天）随机分配至干预组（n = 175）与常规治疗组（n = 175）。患者将在基线、植入后14、26和52周完成以患者为中心的结局评估。随机分配到干预组的患者将在植入后2周开始接受为期12周的基于网络的行为干预。主要终点包括（ii）以患者为中心的结局（即，焦虑、抑郁、ICD接受度、生活质量）;（iii）卫生保健利用;（iii）成本效益。将使用标准化和经验证的疾病特异性或通用问卷评估所有主要终点。次要终点包括（iii）皮质醇觉醒反应;和（iii）室性心律失常。WEBCARE将显示使用基于网络的方法进行行为干预是否可行，是否有效减少焦虑和ICD问题，并改善ICD患者的生活质量。http://www.ClinicalTrials.gov。标识符：NCT 00895700。
The implantable cardioverter defibrillator (ICD) is generally well accepted, but 25-33% of patients experience clinical levels of anxiety, depression, and impaired quality of life (QoL) following implantation. Few trials in ICD patients have investigated whether behavioral intervention may mitigate the development of these adjustment problems. We present the rationale and study design of the WEB-based distress management program for implantable CARdioverter dEfibrillator patients (WEBCARE) trial. WEBCARE is a multi-center, multi-disciplinary, randomized, controlled behavioral intervention trial designed to examine the effectiveness of a web-based approach in terms of reducing levels of anxiety and device concerns and enhancing QoL. Consecutive patients hospitalized for the implantation of an ICD will be approached for study participation while in hospital and randomized to the intervention arm (n = 175) versus usual care (n = 175) at baseline (5-10 days post implantation). Patients will complete assessments of patient-centered outcomes at baseline, 14, 26, and 52 weeks after implantation. Patients randomized to the intervention arm will receive a 12-week web-based behavioral intervention starting 2 weeks after implantation. Primary endpoints include (ii) patient-centered outcomes (i.e., anxiety, depression, ICD acceptance, QoL); (iii) health care utilization; and (iiii) cost-effectiveness. All primary endpoints will be assessed with standardized and validated disease-specific or generic questionnaires. Secondary endpoints include (iii) cortisol awakening response; and (iiii) ventricular arrhythmias. WEBCARE will show whether a behavioral intervention using a web-based approach is feasible and effective in reducing anxiety and ICD concerns and improving QoL in ICD patients. http://www.ClinicalTrials.gov. Identifier: NCT00895700.