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

Research output: Contribution to journalReview articleResearchpeer-review

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 analysis 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.

LanguageEnglish
Article numbere017281
Pages1-12
Number of pages12
JournalBMJ Open
Volume7
Issue number10
DOIs
Publication statusPublished - 1 Oct 2017

Fingerprint

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

Bibliographical note

Copyright the Author(s) 2017. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

  • Adherence
  • Gout
  • Self-management E-health Applications (apps)
  • Urate

Cite this

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 trial protocol. In: BMJ Open. 2017 ; Vol. 7, No. 10. pp. 1-12.
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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 analysis 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.",
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Effectiveness of an electronic patient-centred self-management tool for gout sufferers : a cluster randomised controlled trial 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, p. 1-12.

Research output: Contribution to journalReview articleResearchpeer-review

TY - JOUR

T1 - Effectiveness of an electronic patient-centred self-management tool for gout sufferers

T2 - BMJ Open

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 - Copyright the Author(s) 2017. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

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 analysis 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 analysis 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

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