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Effectiveness of an electronic patient-centred self-management tool for gout sufferers: a cluster randomised
Richard O Day1,2, Lauren J Frensham1,2, Amy D Nguyen1,2
1Department of Clinical Pharmacology & Toxicology, St Vincent's Hospital, Sydney, Australia.
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.
