03186nas a2200373   4500000000100000008004100001100002400042700001600066700002100082700001700103700002000120700001500140700002000155700001600175700001400191700001800205700001900223700001600242700001200258700002100270700002400291700001800315700002400333700002100357700001500378700001500393700002100408700002200429245014000451300001200591490000600603520218900609022001402798       2017                            d1 aBuchbinder Rachelle1 aDay Richard1 aRunciman William1 aHunter David1 aFrensham Lauren1 aNguyen Amy1 aBaysari Melissa1 aAung Eindra1 aLau Annie1 aZwar Nicholas1 aReath Jennifer1 aLaba Tracey1 aLi Ling1 aMcLachlan Andrew1 aClay-Williams Robyn1 aCoiera Enrico1 aBraithwaite Jeffrey1 aH McNeil Patrick1 aPile Kevin1 aPortek Ian1 aWIlliams Kenneth1 aWestbrook Johanna00aEffectiveness of an electronic patient-centred self-management tool for gout sufferers: a cluster randomised controlled trial protocol.  ae0172810 v73 a<p><b>INTRODUCTION: </b>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.</p><p><b>METHODS AND ANALYSIS: </b>Setting and designPrimary care. A prospective, cluster randomised (by general practitioner (GP) practices), controlled trial.</p><p><b>PARTICIPANTS: </b>GP practices will be randomised to either intervention or control clusters with their patients allocated to the same cluster.</p><p><b>INTERVENTION: </b>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.</p><p><b>PRIMARY AND SECONDARY OUTCOMES: </b>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%.</p><p><b>ETHICS AND DISSEMINATION: </b>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.</p><p><b>TRIAL REGISTRATION NUMBER: </b>ACTRN12616000455460.</p>  a2044-6055