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

Richard O. Day, Lauren J. Frensham, Amy D. Nguyen, Melissa T. Baysari, Eindra Aung, Annie Y.S. Lau, Nicholas Zwar, Jennifer Reath, Tracey Laba, Ling Li, Andrew McLachlan, William B. Runciman, Rachelle Buchbinder, Robyn Clay-Williams, Enrico Coiera, Jeffrey Braithwaite, H. Patrick McNeil, David J. Hunter, Kevin J. Pile, Ian Portek & 2 others Kenneth Mapson Williams, Johanna I. Westbrook

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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, 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.

Original languageEnglish
Article numbere017281
JournalBMJ Open
Volume7
Issue number10
DOIs
Publication statusPublished - 1 Oct 2017
Externally publishedYes

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Gout
Self Care
Uric Acid
Serum
General Practice
General Practitioners
Therapeutics
Control Groups
New South Wales
Research Ethics Committees
Ethics
Cost-Benefit Analysis
Primary Health Care
Quality of Life

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Day, R. O., Frensham, L. J., Nguyen, A. D., Baysari, M. T., Aung, E., Lau, A. Y. S., ... Westbrook, J. I. (2017). Effectiveness of an electronic patient-centred self-management tool for gout sufferers: A cluster randomised controlled trail protocol. BMJ Open, 7(10), [e017281]. https://doi.org/10.1136/bmjopen-2017-017281
Day, Richard O. ; Frensham, Lauren J. ; Nguyen, Amy D. ; Baysari, Melissa T. ; Aung, Eindra ; Lau, Annie Y.S. ; Zwar, Nicholas ; Reath, Jennifer ; Laba, Tracey ; Li, Ling ; McLachlan, Andrew ; Runciman, William B. ; Buchbinder, Rachelle ; Clay-Williams, Robyn ; Coiera, Enrico ; Braithwaite, Jeffrey ; McNeil, H. Patrick ; Hunter, David J. ; Pile, Kevin J. ; Portek, Ian ; Williams, Kenneth Mapson ; Westbrook, Johanna I. / Effectiveness of an electronic patient-centred self-management tool for gout sufferers : A cluster randomised controlled trail protocol. In: BMJ Open. 2017 ; Vol. 7, No. 10.
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title = "Effectiveness of an electronic patient-centred self-management tool for gout sufferers: A cluster randomised controlled trail 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, 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.",
author = "Day, {Richard O.} and Frensham, {Lauren J.} and Nguyen, {Amy D.} and Baysari, {Melissa T.} and Eindra Aung and Lau, {Annie Y.S.} and Nicholas Zwar and Jennifer Reath and Tracey Laba and Ling Li and Andrew McLachlan and Runciman, {William B.} and Rachelle Buchbinder and Robyn Clay-Williams and Enrico Coiera and Jeffrey Braithwaite and McNeil, {H. Patrick} and Hunter, {David J.} and Pile, {Kevin J.} and Ian Portek and Williams, {Kenneth Mapson} and Westbrook, {Johanna I.}",
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Day, RO, Frensham, LJ, Nguyen, AD, Baysari, MT, Aung, E, Lau, AYS, Zwar, N, Reath, J, Laba, T, Li, L, McLachlan, A, Runciman, WB, Buchbinder, R, Clay-Williams, R, Coiera, E, Braithwaite, J, McNeil, HP, Hunter, DJ, Pile, KJ, Portek, I, Williams, KM & Westbrook, JI 2017, 'Effectiveness of an electronic patient-centred self-management tool for gout sufferers: A cluster randomised controlled trail protocol' BMJ Open, vol. 7, no. 10, e017281. https://doi.org/10.1136/bmjopen-2017-017281

Effectiveness of an electronic patient-centred self-management tool for gout sufferers : A cluster randomised controlled trail protocol. / Day, Richard O.; Frensham, Lauren J.; Nguyen, Amy D.; Baysari, Melissa T.; Aung, Eindra; Lau, Annie Y.S.; Zwar, Nicholas; Reath, Jennifer; Laba, Tracey; Li, Ling; McLachlan, Andrew; Runciman, William B.; Buchbinder, Rachelle; Clay-Williams, Robyn; Coiera, Enrico; Braithwaite, Jeffrey; McNeil, H. Patrick; Hunter, David J.; Pile, Kevin J.; Portek, Ian; Williams, Kenneth Mapson; Westbrook, Johanna I.

In: BMJ Open, Vol. 7, No. 10, e017281, 01.10.2017.

Research output: Contribution to journalReview articleResearchpeer-review

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.

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.

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

VL - 7

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 10

M1 - e017281

ER -