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

dc.contributor.authorDay, R.O.
dc.contributor.authorFrensham, L.J.
dc.contributor.authorNguyen, A.D.
dc.contributor.authorBaysari, M.T.
dc.contributor.authorLaba, T.L.
dc.contributor.authorRunciman, W.B.
dc.contributor.authorWestbrook, J.I.
dc.date.issued2017
dc.description.abstractIntroduction 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, a'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 analysisSetting 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 a'dropout' rate 20%.
dc.identifier.citationBMJ Open, 2017; 7(10, article no. e017281):1-13
dc.identifier.doi10.1136/bmjopen-2017-017281
dc.identifier.issn2044-6055
dc.identifier.issn2044-6055
dc.identifier.urihttps://hdl.handle.net/11541.2/129081
dc.language.isoen
dc.publisherIEEE
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/1054146
dc.rightsCopyright 2017 Article author(s) (or their employer(s) unless otherwise stated in the text of the article)
dc.source.urihttps://doi.org/10.1136/bmjopen-2017-017281
dc.subjectadherence
dc.subjectgout
dc.subjectself management e-health applications (apps)
dc.subjecturate
dc.titleEffectiveness of an electronic patient-centred self-management tool for gout sufferers: a cluster randomised controlled trail protocol
dc.typeJournal article
pubs.publication-statusPublished
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