Article Text
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.
Setting and design Primary 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.
- Gout
- Urate
- Adherence
- Self-management E-health Applications (apps)
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Footnotes
Contributors All authors contributedto study design and the final manuscript; ADN, MTB, AYSL, NZ, JR, AM, WR, RC-W,EC, JB, DH, KP, IP and KMW contributed to selection outcomes; ROD conceived thestudy, led the grant application to seek funding, led the discussions regardingstudy design and led the revision of draft manuscripts; LJF was projectmanager*, wrote the draft manuscript, revised multiple versions and liaisedwith investigators; ADN led and contributed to pilot testing of the ‘app’; MTB contributedespecially to the human factors aspects of the app development; EA becameproject manager after LJF, revised the manuscript, consolidated outcomemeasures and prepared the response to referees and editor; AYSL contributed tothe modification of the Healthy.Me app for people with gout; NZ contributed especiallyto the primary care aspects, analytical considerations particularly the clusterdesign; JR contributed especially to the primary care aspects; TL-L contributedto the design relevant to cost-effectiveness, analytical considerations; LL contributedespecially to the power calculations; AM advised on pharmaceutical aspects; WR andRB contributed especially to the educational material in the app; RB providedexpertise with respect to gout; RC-W contributed to the design and modificationof the HealthyMe app for people with gout; EC contributed to the eHealthaspects of the study; JB, contributed to the ‘health systems’ aspects of thestudy; HPM, DH, KP and IP provided expertise with respect to gout, especiallythe educational content of the app; JIW contributed to the eHealthmethodological aspects of the study.* Resigned December 2016.
Funding This study is supported by a National Health and Medical Research Council (Australia) Partnership Grant APP1094708 and Programme Grant APP1054146. The Trial Investigator and the research team will conduct study design development, trial coordination, data management and interpretation, writing of the report and submitting the report for publication independent of the funding agency.
Competing interests None declared.
Ethics approval University of New South Wales Human Research Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All data from this study will be made available freely without limitation.
Correction notice This article has been corrected since it first published. The author ’Kevin J Pile' has been corrected to ’Kevin D Pile'.