植入式心律转复除颤器患者基于网络的应激管理项目（WEBCARE）中的失访与依从性：随机对照试验
Attrition and adherence in a WEB-Based Distress Management Program for Implantable Cardioverter defibrillator Patients (WEBCARE): randomized controlled trial.
作者信息
Habibović Mirela, Cuijpers Pim, Alings Marco, van der Voort Pepijn, Theuns Dominic, Bouwels Leon, Herrman Jean-Paul, Valk Suzanne, Pedersen Susanne
机构信息
Center of Research on Psychology in Somatic Diseases, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands.
出版信息
J Med Internet Res. 2014 Feb 28;16(2):e52. doi: 10.2196/jmir.2809.
BACKGROUND
WEB-Based Distress Management Program for Implantable CARdioverter defibrillator Patients (WEBCARE) is a Web-based randomized controlled trial, designed to improve psychological well-being in patients with an implantable cardioverter defibrillator (ICD). As in other Web-based trials, we encountered problems with attrition and adherence.
OBJECTIVE
In the current study, we focus on the patient characteristics, reasons, and motivation of (1) completers, (2) those who quit the intervention, and (3) those who quit the intervention and the study in the treatment arm of WEBCARE.
METHODS
Consecutive first-time ICD patients from six Dutch referral hospitals were approached for participation. After signing consent and filling in baseline measures, patients were randomized to either the WEBCARE group or the Usual Care group.
RESULTS
The treatment arm of WEBCARE contained 146 patients. Of these 146, 34 (23.3%) completed the treatment, 88 (60.3%) dropped out of treatment but completed follow-up, and 24 (16.4%) dropped out of treatment and study. Results show no systematic differences in baseline demographic, clinical, or psychological characteristics between groups. A gradual increase in dropout was observed with 83.5% (122/146) completing the first lesson, while only 23.3% (34/146) eventually completed the whole treatment. Reasons most often given by patients for dropout were technical problems with the computer, time constraints, feeling fine, and not needing additional support.
CONCLUSIONS
Current findings underline the importance of focusing on adherence and dropout, as this remains a significant problem in behavioral Web-based trials. Examining possibilities to address barriers indicated by patients might enhance treatment engagement and improve patient outcomes.
TRIAL REGISTRATION
Clinicaltrials.gov: NCT00895700; http://www.clinicaltrials.gov/ct2/show/NCT00895700 (Archived by WebCite at http://www.webcitation.org/6NCop6Htz).
背景
基于网络的植入式心脏复律除颤器患者应激管理项目（WEBCARE）是一项基于网络的随机对照试验，旨在改善植入式心脏复律除颤器（ICD）患者的心理健康状况。与其他基于网络的试验一样，我们遇到了损耗和依从性方面的问题。
目的
在当前研究中，我们聚焦于WEBCARE治疗组中（1）完成治疗者、（2）退出干预者以及（3）退出干预和研究的患者的特征、原因及动机。
方法
我们邀请了来自荷兰六家转诊医院的首次植入ICD的连续患者参与研究。在签署知情同意书并填写基线测量表后，患者被随机分为WEBCARE组或常规护理组。
结果
WEBCARE治疗组有146名患者。在这146名患者中，34名（23.3%）完成了治疗，88名（60.3%）退出了治疗但完成了随访，24名（16.4%）退出了治疗和研究。结果显示，两组在基线人口统计学、临床或心理特征方面没有系统性差异。观察到损耗逐渐增加，83.5%（122/146）的患者完成了第一课，而最终只有23.3%（34/146）的患者完成了整个治疗。患者最常给出的退出原因是计算机技术问题、时间限制、感觉良好以及不需要额外支持。
结论
当前研究结果强调了关注依从性和损耗的重要性，因为这在基于网络的行为试验中仍然是一个重大问题。研究解决患者指出的障碍的可能性，可能会提高治疗参与度并改善患者结局。
试验注册
Clinicaltrials.gov：NCT00895700；http://www.clinicaltrials.gov/ct2/show/NCT00895700（由WebCite存档于http://www.webcitation.org/6NCop6Htz）
Zotero 插件