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Effectiveness of an electronic patient-centred self-management tool for gout sufferers: a cluster randomised controlled trial protocol.
BMJ Open. 2017 10 16; 7(10):e017281.BO

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.

Links

PMC Free PDF

Authors+Show Affiliations

Day RO
Department of Clinical Pharmacology & Toxicology, St Vincent's Hospital, Sydney, Australia. St Vincent's Clinical School, St Vincent's Hospital, University of New South Wales, Sydney, Australia.
Frensham LJ
Department of Clinical Pharmacology & Toxicology, St Vincent's Hospital, Sydney, Australia. St Vincent's Clinical School, St Vincent's Hospital, University of New South Wales, Sydney, Australia.
Nguyen AD
Department of Clinical Pharmacology & Toxicology, St Vincent's Hospital, Sydney, Australia. St Vincent's Clinical School, St Vincent's Hospital, University of New South Wales, Sydney, Australia.
Baysari MT
Department of Clinical Pharmacology & Toxicology, St Vincent's Hospital, Sydney, Australia. Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Sydney, Australia.
Aung E
Department of Clinical Pharmacology & Toxicology, St Vincent's Hospital, Sydney, Australia. St Vincent's Clinical School, St Vincent's Hospital, University of New South Wales, Sydney, Australia.
Lau AYS
Centre for Health Informatics, Australian Institute of Health Innovation, Macquarie University, Sydney, Australia.
Zwar N
School of Public Health and Community Medicine, Faculty of Medicine, University of New South Wales, Sydney, Australia.
Reath J
School of Medicine, Western Sydney University, Sydney, Australia.
Laba T
The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, Australia. The Menzies Centre for Health Policy, Sydney Medical School, The University of Sydney, Sydney, Australia. The Centre for Clinical Epidemiology and Evaluation, The University of British Columbia, Vancouver, Canada.
Li L
Centre for Health Informatics, Australian Institute of Health Innovation, Macquarie University, Sydney, Australia.
McLachlan A
Faculty of Pharmacy and Centre for Education and Research on Ageing, University of Sydney, Sydney, Australia.
Runciman WB
School of Health Sciences, University of South Australia, Adelaide, Australia.
Buchbinder R
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.
Clay-Williams R
Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Sydney, Australia.
Coiera E
Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Sydney, Australia.
Braithwaite J
Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Sydney, Australia.
McNeil HP
Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Sydney, Australia.
Hunter DJ
Institute of Bone and Joint Research, Kolling Institute, Sydney Medical School, The University of Sydney, Sydney, Australia. Department of Rheumatology, Royal North Shore Hospital, Sydney, Australia.
Pile KD
Department of Medicine, Western Sydney University, Sydney, Australia. Department of Rheumatology, Campbelltown Hospital, Sydney, Australia.
Portek I
St George and Sutherland Clinical School, Faculty of Medicine, University of New South Wales, Sydney, Australia. Department of Rheumatology, St George Hospital, Sydney, Australia.
WIlliams KM
Department of Clinical Pharmacology & Toxicology, St Vincent's Hospital, Sydney, Australia. St Vincent's Clinical School, St Vincent's Hospital, University of New South Wales, Sydney, Australia.
Westbrook JI
Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Sydney, Australia.

MeSH

AllopurinolGoutGout SuppressantsHumansInternetPatient ComplianceProspective StudiesQuality of LifeResearch DesignSelf-ManagementUric Acid

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

29042386

Citation

Day, Richard O., et al. "Effectiveness of an Electronic Patient-centred Self-management Tool for Gout Sufferers: a Cluster Randomised Controlled Trial Protocol." BMJ Open, vol. 7, no. 10, 2017, pp. e017281.
Day RO, Frensham LJ, Nguyen AD, et al. Effectiveness of an electronic patient-centred self-management tool for gout sufferers: a cluster randomised controlled trial protocol. BMJ Open. 2017;7(10):e017281.
Day, R. O., Frensham, L. J., Nguyen, A. D., Baysari, M. T., Aung, E., Lau, A. Y. S., Zwar, N., Reath, J., Laba, T., Li, L., McLachlan, A., Runciman, W. B., Buchbinder, R., Clay-Williams, R., Coiera, E., Braithwaite, J., McNeil, H. P., Hunter, D. J., Pile, K. D., ... Westbrook, J. I. (2017). Effectiveness of an electronic patient-centred self-management tool for gout sufferers: a cluster randomised controlled trial protocol. BMJ Open, 7(10), e017281. https://doi.org/10.1136/bmjopen-2017-017281
Day RO, et al. Effectiveness of an Electronic Patient-centred Self-management Tool for Gout Sufferers: a Cluster Randomised Controlled Trial Protocol. BMJ Open. 2017 10 16;7(10):e017281. PubMed PMID: 29042386.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effectiveness of an electronic patient-centred self-management tool for gout sufferers: a cluster randomised controlled trial 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 D, AU - Portek,Ian, AU - WIlliams,Kenneth Mapson, AU - Westbrook,Johanna I, Y1 - 2017/10/16/ PY - 2017/10/19/entrez PY - 2017/10/19/pubmed PY - 2018/6/9/medline KW - Adherence KW - Gout KW - Self-management E-health Applications (apps) KW - Urate SP - e017281 EP - e017281 JF - BMJ open JO - BMJ Open VL - 7 IS - 10 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, '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. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/29042386/Effectiveness_of_an_electronic_patient_centred_self_management_tool_for_gout_sufferers:_a_cluster_randomised_controlled_trial_protocol_ DB - PRIME DP - Unbound Medicine ER -