Lakshminarayana Rashmi, Wang Duolao, Burn David, Chaudhuri K Ray, Cummins Gemma, Galtrey Clare, Hellman Bruce, Pal Suvankar, Stamford Jon, Steiger Malcolm, Williams Adrian
uMotif Ltd, London, UK.
Trials. 2014 Sep 25;15:374. doi: 10.1186/1745-6215-15-374.
Nonadherence to treatment leads to suboptimal treatment outcomes and enormous costs to the economy. This is especially important in Parkinson's disease (PD). The progressive nature of the degenerative process, the complex treatment regimens and the high rates of comorbid conditions make treatment adherence in PD a challenge. Clinicians have limited face-to-face consultation time with PD patients, making it difficult to comprehensively address non-adherence. The rapid growth of digital technologies provides an opportunity to improve adherence and the quality of decision-making during consultation. The aim of this randomised controlled trial (RCT) is to evaluate the impact of using a smartphone and web applications to promote patient self-management as a tool to increase treatment adherence and working with the data collected to enhance the quality of clinical consultation.
METHODS/DESIGN: A 4-month multicentre RCT with 222 patients will be conducted to compare use of a smartphone- and internet-enabled Parkinson's tracker smartphone app with treatment as usual for patients with PD and/or their carers. The study investigators will compare the two groups immediately after intervention. Seven centres across England (6) and Scotland (1) will be involved. The primary objective of this trial is to assess whether patients with PD who use the app show improved medication adherence compared to those receiving treatment as usual alone. The secondary objectives are to investigate whether patients who receive the app and those who receive treatment as usual differ in terms of quality of life, quality of clinical consultation, overall disease state and activities of daily living. We also aim to investigate the experience of those receiving the intervention by conducting qualitative interviews with a sample of participants and clinicians, which will be administered by independent researchers.
ISRCTN45824264 (registered 5 November 2013).
治疗依从性差会导致治疗效果欠佳，并给经济带来巨大成本。这在帕金森病（PD）中尤为重要。退行性病变的进展特性、复杂的治疗方案以及高合并症发生率使得PD患者的治疗依从性成为一项挑战。临床医生与PD患者面对面咨询的时间有限，难以全面解决不依从问题。数字技术的迅速发展为提高依从性以及咨询期间的决策质量提供了契机。这项随机对照试验（RCT）的目的是评估使用智能手机和网络应用程序来促进患者自我管理作为一种提高治疗依从性的工具，并利用收集到的数据来提高临床咨询质量的影响。
方法/设计：将开展一项为期4个月的多中心RCT，纳入222名患者，比较使用具备智能手机和互联网功能的帕金森追踪器智能手机应用程序与常规治疗对PD患者及其护理人员的效果。研究人员将在干预后立即比较两组情况。英格兰的6个中心和苏格兰的1个中心将参与其中。该试验的主要目的是评估使用该应用程序的PD患者与仅接受常规治疗的患者相比，药物依从性是否有所改善。次要目的是调查接受该应用程序的患者与接受常规治疗的患者在生活质量、临床咨询质量、整体疾病状态和日常生活活动方面是否存在差异。我们还旨在通过对部分参与者和临床医生进行定性访谈来调查接受干预者的体验，访谈将由独立研究人员进行。
ISRCTN45824264（2013年11月5日注册）。
