101. Effectiveness of an electronic patient-centred self-management tool for gout sufferers: a cluster randomised controlled trial protocol.
- Author
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Day RO, Frensham LJ, Nguyen AD, Baysari MT, Aung E, Lau AYS, Zwar N, Reath J, Laba T, Li L, McLachlan A, Runciman WB, Buchbinder R, Clay-Williams R, Coiera E, Braithwaite J, McNeil HP, Hunter DJ, Pile KD, Portek I, WIlliams KM, and Westbrook JI
- Subjects
- Allopurinol therapeutic use, Gout Suppressants therapeutic use, Humans, Patient Compliance, Prospective Studies, Quality of Life, Uric Acid blood, Gout therapy, Internet, Research Design, Self-Management methods
- 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., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)
- Published
- 2017
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