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Employment and Arthritis: Making It Work a Randomized Controlled Trial Evaluating an Online Program to Help People with Inflammatory Arthritis Maintain Employment (Study Protocol)

机译:就业与关节炎:使其工作成为一项随机对照试验,评估一项在线计划,以帮助炎症性关节炎患者维持就业(研究协议)

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摘要

BackgroundArthritis and musculoskeletal conditions are the leading cause of long-term work disability (WD), an outcome with a major impact on quality of life and a high cost to society. The importance of decreased at-work productivity has also recently been recognized. Despite the importance of these problems, few interventions have been developed to reduce the impact of arthritis on employment. We have developed a novel intervention called “Making It Work”, a program to help people with inflammatory arthritis (IA) deal with employment issues, prevent WD and improve at-work productivity. After favorable results in a proof-of-concept study, we converted the program to a web-based format for broader dissemination and improved accessibility. The objectives of this study are: 1) to evaluate in a randomized controlled trial (RCT) the effectiveness of the program at preventing work cessation and improving at-work productivity; 2) to perform a cost-utility analysis of the intervention.Methods/Design526 participants with IA will be recruited from British Columbia, Alberta, and Ontario in Canada. The intervention consists of a) 5 online group sessions; b) 5 web-based e-learning modules; c) consultations with an occupational therapist for an ergonomic work assessment and a vocational rehabilitation counselor. Questionnaires will be administered online at baseline and every 6 months to collect information about demographics, disease measures, costs, work-related risk factors for WD, quality of life, and work outcomes. Primary outcomes include at-work productivity and time to work cessation of  6 months for any reason. Secondary outcomes include temporary work cessation, number of days missed from work per year, reduction in hours worked per week, quality adjusted life year for the cost utility analysis, and changes from baseline in employment risk factors. Analysis of Variance will evaluate the intervention’s effect on at-work productivity, and multivariable Cox regression models will estimate the risk of work cessation associated with the intervention after controlling for risk factors for WD and other important predictors imbalanced at baseline.DiscussionThis program fills an important gap in arthritis health services and addresses an important and costly problem. Knowledge gained from the RCT will be useful to health care professionals, policy planners and arthritis stakeholders.Trial registrationClinicalTrials.gov NCT01852851; registered April 13, 2012; first participant randomized on July 6, 2013.
机译:背景技术关节炎和肌肉骨骼疾病是长期工作残障(WD)的主要原因,其结果对生活质量产生重大影响,并给社会带来高昂的成本。最近还认识到降低工作效率的重要性。尽管这些问题很重要,但很少有干预措施可以减少关节炎对就业的影响。我们已经开发了一种新颖的干预措施,称为“使之起作用”,该计划旨在帮助炎症性关节炎(IA)的人解决就业问题,预防WD和提高工作效率。在概念验证研究中取得令人满意的结果后,我们将该程序转换为基于Web的格式,以更广泛地传播和改善可访问性。这项研究的目的是:1)在一项随机对照试验(RCT)中评估该计划在防止工作中断和提高工作效率方面的有效性; 2)对该干预措施进行成本-效用分析。方法/设计526与IA的参与者将从加拿大不列颠哥伦比亚省,艾伯塔省和安大略省招募。干预措施包括:a)5个在线小组会议; b)5个基于网络的电子学习模块; c)与职业治疗师进行人体工程学评估和职业康复咨询。问卷调查将在基线和每6个月在线进行,以收集有关人口统计学,疾病测度,成本,与工作相关的WD危险因素,生活质量和工作成果的信息。主要结果包括因任何原因导致的工作效率和productivity> 6个月的工作停止时间。次要结果包括暂时停止工作,每年缺勤天数,每周工作小时数减少,成本效用分析的质量调整生命年以及就业风险因素相对于基线的变化。方差分析将评估干预措施对工作效率的影响,多变量Cox回归模型将在控制WD和其他在基线时失衡的重要预测因素的风险因素之后估算与干预措施相关的停工风险。关节炎保健服务方面的差距,并解决了一个重要且代价高昂的问题。从RCT获得的知识将对医疗保健专业人员,政策计划者和关节炎的利益相关者有用。试验注册临床试验Trial.gov NCT01852851; 2012年4月13日注册;首位参与者于2013年7月6日随机分组。

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