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 D Pile; Ian Portek; Kenneth Mapson WIlliams; Johanna I Westbrook

doi:10.1136/bmjopen-2017-017281

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

BMJ Open. 2017 Oct 16;7(10):e017281. doi: 10.1136/bmjopen-2017-017281.

Authors

Richard O Day^{1

2}, Lauren J Frensham^{1

2}, Amy D Nguyen^{1

2}, Melissa T Baysari^{1

3}, Eindra Aung^{1

2}, Annie Y S Lau⁴, Nicholas Zwar⁵, Jennifer Reath⁶, Tracey Laba^{7

8

9}, Ling Li⁴, Andrew McLachlan¹⁰, William B Runciman¹¹, Rachelle Buchbinder¹², Robyn Clay-Williams³, Enrico Coiera³, Jeffrey Braithwaite³, H Patrick McNeil³, David J Hunter^{13

14}, Kevin D Pile^{15

16}, Ian Portek^{17

18}, Kenneth Mapson WIlliams^{1

2}, Johanna I Westbrook³

Affiliations

¹ Department of Clinical Pharmacology & Toxicology, St Vincent's Hospital, Sydney, Australia.
² St Vincent's Clinical School, St Vincent's Hospital, University of New South Wales, Sydney, Australia.
³ Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Sydney, Australia.
⁴ Centre for Health Informatics, Australian Institute of Health Innovation, Macquarie University, Sydney, Australia.
⁵ School of Public Health and Community Medicine, Faculty of Medicine, University of New South Wales, Sydney, Australia.
⁶ School of Medicine, Western Sydney University, Sydney, Australia.
⁷ The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, Australia.
⁸ The Menzies Centre for Health Policy, Sydney Medical School, The University of Sydney, Sydney, Australia.
⁹ The Centre for Clinical Epidemiology and Evaluation, The University of British Columbia, Vancouver, Canada.
¹⁰ Faculty of Pharmacy and Centre for Education and Research on Ageing, University of Sydney, Sydney, Australia.
¹¹ School of Health Sciences, University of South Australia, Adelaide, Australia.
¹² Monash Department of Clinical Epidemiology, Cabrini Institute and Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
¹³ Institute of Bone and Joint Research, Kolling Institute, Sydney Medical School, The University of Sydney, Sydney, Australia.
¹⁴ Department of Rheumatology, Royal North Shore Hospital, Sydney, Australia.
¹⁵ Department of Medicine, Western Sydney University, Sydney, Australia.
¹⁶ Department of Rheumatology, Campbelltown Hospital, Sydney, Australia.
¹⁷ St George and Sutherland Clinical School, Faculty of Medicine, University of New South Wales, Sydney, Australia.
¹⁸ Department of Rheumatology, St George Hospital, Sydney, Australia.

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.

Methods and analysis: Setting and designPrimary 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.

Keywords: Adherence; Gout; Self-management E-health Applications (apps); Urate.

Publication types

Multicenter Study
Randomized Controlled Trial

MeSH terms

Allopurinol / therapeutic use
Gout / therapy*
Gout Suppressants / therapeutic use
Humans
Internet*
Patient Compliance
Prospective Studies
Quality of Life
Research Design*
Self-Management / methods*
Uric Acid / blood

Substances

Gout Suppressants
Uric Acid
Allopurinol