一种以患者为中心的痛风患者电子自我管理工具的有效性：一项整群随机对照试验方案

Effectiveness of an electronic patient-centred self-management tool for gout sufferers: a cluster randomised controlled trial protocol.

作者信息

Day Richard O, Frensham Lauren J, Nguyen Amy D, Baysari Melissa T, Aung Eindra, Lau Annie Y S, Zwar Nicholas, Reath Jennifer, Laba Tracey, Li Ling, McLachlan Andrew, Runciman William B, Buchbinder Rachelle, Clay-Williams Robyn, Coiera Enrico, Braithwaite Jeffrey, McNeil H Patrick, Hunter David J, Pile Kevin D, Portek Ian, WIlliams Kenneth Mapson, Westbrook Johanna I

机构信息

Department of Clinical Pharmacology & Toxicology, St Vincent's Hospital, Sydney, Australia.

St Vincent's Clinical School, St Vincent's Hospital, University of New South Wales, Sydney, Australia.

出版信息

BMJ Open. 2017 Oct 16;7(10):e017281. doi: 10.1136/bmjopen-2017-017281.

DOI:10.1136/bmjopen-2017-017281

PMID:29042386

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5652564/

Abstract

INTRODUCTION

Gout is increasing despite effective therapies to lower serum urate concentrations to 0.36 mmol/L or less, which, if sustained, significantly reduces acute attacks of gout. Adherence to urate-lowering therapy (ULT) is poor, with rates of less than 50% 1 year after initiation of ULT. Attempts to increase adherence in gout patients have been disappointing. We aim to evaluate the effectiveness of use of a personal, self-management, 'smartphone' application (app) to achieve target serum urate concentrations in people with gout. We hypothesise that personalised feedback of serum urate concentrations will improve adherence to ULT.

METHODS AND ANALYSIS

Setting and designPrimary care. A prospective, cluster randomised (by general practitioner (GP) practices), controlled trial.

PARTICIPANTS

GP practices will be randomised to either intervention or control clusters with their patients allocated to the same cluster.

INTERVENTION

The intervention group will have access to the Healthy.me app tailored for the self-management of gout. The control group patients will have access to the same app modified to remove all functions except the Gout Attack Diary.

PRIMARY AND SECONDARY OUTCOMES

The proportion of patients whose serum urate concentrations are less than or equal to 0.36 mmol/L after 6 months. Secondary outcomes will be proportions of patients achieving target urate concentrations at 12 months, ULT adherence rates, serum urate concentrations at 6 and 12 months, rates of attacks of gout, quality of life estimations and process and economic evaluations. The study is designed to detect a ≥30% improvement in the intervention group above the expected 50% achievement of target serum urate at 6 months in the control group: power 0.80, significance level 0.05, assumed 'dropout' rate 20%.

ETHICS AND DISSEMINATION

This study has been approved by the University of New South Wales Human Research Ethics Committee. Study findings will be disseminated in international conferences and peer-reviewed journal.

TRIAL REGISTRATION NUMBER

ACTRN12616000455460.

摘要

引言

尽管有有效的疗法可将血清尿酸盐浓度降至0.36 mmol/L或更低，且若能维持该浓度，可显著减少痛风急性发作，但痛风发病率仍在上升。尿酸盐降低疗法（ULT）的依从性较差，ULT开始后1年的依从率低于50%。提高痛风患者依从性的尝试一直令人失望。我们旨在评估使用个人自我管理的“智能手机”应用程序（app）使痛风患者达到目标血清尿酸盐浓度的有效性。我们假设血清尿酸盐浓度的个性化反馈将提高ULT的依从性。

方法与分析

设置与设计

基层医疗。一项前瞻性、整群随机（按全科医生诊所）对照试验。

参与者

全科医生诊所将被随机分为干预组或对照组，其患者被分配到同一组。

干预

干预组将可以使用为痛风自我管理量身定制的Healthy.me应用程序。对照组患者将可以使用经过修改的同一应用程序，该程序除痛风发作日记外的所有功能均被移除。

主要和次要结局

6个月后血清尿酸盐浓度小于或等于0.36 mmol/L的患者比例。次要结局将是12个月时达到目标尿酸盐浓度的患者比例、ULT依从率、6个月和12个月时的血清尿酸盐浓度、痛风发作率、生活质量评估以及过程和经济评估。该研究旨在检测干预组比对照组预期的6个月时50%的目标血清尿酸盐达成率提高≥30%：检验效能0.80,显著性水平0.05，假定“退出”率20%。