TY - JOUR
T1 - Effectiveness of an electronic patient-centred self-management tool for gout sufferers
T2 - A cluster randomised controlled trail protocol
AU - Day, Richard O.
AU - Frensham, Lauren J.
AU - Nguyen, Amy D.
AU - Baysari, Melissa T.
AU - Aung, Eindra
AU - Lau, Annie Y.S.
AU - Zwar, Nicholas
AU - Reath, Jennifer
AU - Laba, Tracey
AU - Li, Ling
AU - McLachlan, Andrew
AU - Runciman, William B.
AU - Buchbinder, Rachelle
AU - Clay-Williams, Robyn
AU - Coiera, Enrico
AU - Braithwaite, Jeffrey
AU - McNeil, H. Patrick
AU - Hunter, David J.
AU - Pile, Kevin J.
AU - Portek, Ian
AU - Williams, Kenneth Mapson
AU - Westbrook, Johanna I.
N1 - Publisher 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.
PY - 2017/10/1
Y1 - 2017/10/1
N2 - 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, 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%. 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.
AB - 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, 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%. 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.
KW - Adherence
KW - Gout
KW - Self-management E-health Applications (apps)
KW - Urate
UR - http://www.scopus.com/inward/record.url?scp=85031800724&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2017-017281
DO - 10.1136/bmjopen-2017-017281
M3 - Review article
C2 - 29042386
AN - SCOPUS:85031800724
SN - 2044-6055
VL - 7
JO - BMJ open
JF - BMJ open
IS - 10
M1 - e017281
ER -