Dataset Information

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.

SUBMITTER: Day RO

PROVIDER: S-EPMC5652564 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Publications

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

Day Richard O RO Frensham Lauren J LJ Nguyen Amy D AD Baysari Melissa T MT Aung Eindra E Lau Annie Y S AYS Zwar Nicholas N Reath Jennifer J Laba Tracey T Li Ling L McLachlan Andrew A Runciman William B WB Buchbinder Rachelle R Clay-Williams Robyn R Coiera Enrico E Braithwaite Jeffrey J McNeil H Patrick HP Hunter David J DJ Pile Kevin D KD Portek Ian I WIlliams Kenneth Mapson KM Westbrook Johanna I JI

BMJ open 20171016 10

<h4>Introduction</h4>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 targ ...[more]

PMID: 29042386

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Dataset Information

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

Introduction

Methods and analysis

Participants

Intervention

Primary and secondary outcomes

Ethics and dissemination

Trial registration number

Publications

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

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