Breakey V R, Ignas D M, Warias A V, White M, Blanchette V S, Stinson J N
Department of Pediatrics, McMaster Children's Hospital, Hamilton, ON, Canada; Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
Haemophilia. 2014 Nov;20(6):784-93. doi: 10.1111/hae.12488. Epub 2014 Oct 14.
Adolescents with haemophilia must assume responsibility for their health and management of their disease. An online self-management program was developed to support adolescents during this transition. To determine the feasibility of the program using a randomized control trial (RCT) design in terms of accrual/attrition rates, willingness to be randomized, compliance with the program/outcome measures and satisfaction. Adolescents, ages 13-18, were enrolled in a pilot RCT (NCT01477437) and randomized to either the intervention (8-week program with telephone coaching) or the control arm (no access to the website, weekly telephone call as attention-strategy). All participants completed pre/post-outcome measures. Twenty-nine teens participated (intervention n = 16, control n = 13). Participants in the intervention arm spent an average of 50 min on the website per week and completed the modules in an average of 14 weeks (SD = 4.9). Attrition was higher in the control group compared to the intervention group (54% vs. 25%). 17/18 (94%) who completed the program also completed the poststudy measures. Teens on the intervention arm showed significant improvement in disease-specific knowledge (P = 0.004), self-efficacy (P = 0.007) and transition preparedness (P = 0.046). There was a statistically significant improvement in knowledge in the intervention group when compared to the control group (P = 0.01). Overall, the teens found the website to be informative, comprehensive and easy to use and were satisfied with the program. This pilot RCT study suggests benefit to the program and indicates an RCT design to be feasible with minor adjustments to the protocol.
患有血友病的青少年必须对自己的健康状况及疾病管理负责。为此开发了一个在线自我管理项目，以在这一过渡阶段为青少年提供支持。通过随机对照试验（RCT）设计，从入组/失访率、随机分组意愿、对项目/结果指标的依从性以及满意度等方面，确定该项目的可行性。年龄在13 - 18岁的青少年参与了一项先导性RCT（NCT01477437），并被随机分为干预组（为期8周的项目，有电话辅导）或对照组（无法访问网站，每周进行一次作为关注策略的电话沟通）。所有参与者均完成了前后结果指标评估。29名青少年参与了研究（干预组n = 16，对照组n = 13）。干预组参与者平均每周在网站上花费50分钟，平均14周完成各个模块（标准差 = 4.9）。与干预组相比，对照组的失访率更高（54%对25%）。完成项目的17/18名（94%）参与者也完成了研究后评估。干预组的青少年在疾病相关知识（P = 0.004）、自我效能感（P = 0.007）和过渡准备方面有显著改善。与对照组相比，干预组的知识水平有统计学意义的提高（P = 0.01）。总体而言，青少年认为该网站信息丰富、内容全面且易于使用，并对该项目感到满意。这项先导性RCT研究表明该项目有益，并表明对方案进行 minor adjustments 后，RCT设计是可行的。 （注：“minor adjustments”直译为“小调整”，结合语境可能是指“细微调整”之类的意思，但因要求不添加解释，所以保留原文）
