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

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.

• Authors: Richard O Day, Lauren J Frensham, Amy D Nguyen, Melissa T Baysari, Eindra Aung, Annie Y S Lau, Nicholas Zwar, Jennifer Reath, Tracey Laba, Ling Li, Andrew McLachlan, William B Runciman, Rachelle Buchbinder, Robyn Clay-Williams, Enrico Coiera, Jeffrey Braithwaite, H Patrick McNeil, David J Hunter, Kevin D Pile, Ian Portek, Kenneth Mapson WIlliams, Johanna I Westbrook
• Journal: BMJ open (BMJ Open) Vol. 7 Issue 10 Pg. e017281 (10 16 2017) ISSN: 2044-6055 [Electronic] England
• PMID: 29042386 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 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.

Chemical References

• Gout Suppressants
• Uric Acid
• Allopurinol

Topics

• Allopurinol (therapeutic use)
• Gout (therapy)
• Gout Suppressants (therapeutic use)
• Humans
• Internet
• Patient Compliance
• Prospective Studies
• Quality of Life
• Research Design
• Self-Management (methods)
• Uric Acid (blood)