None listed
Conditions
Brief summary
Gout is a common condition, associated with significant illness, and costs to the community and the health care system. However, people with gout generally don’t get good treatment, the health system is failing to provide appropriate care for these people using the routine health care systems in Australia. We aim to develop an educational programme to be delivered in the patient’s home, along with escalation of medicines, to see if this improves the treatment of people with gout.
Interventions
Person centred structured educational intervention (PC-SEV): Two home visits (at weeks 2 and 6) of approximately 1 hour, will be undertaken to deliver individualised structured education focused around key messages that are determined a priori.
A health professional ( nurse or pharmacist) will visit the patients home, and deliver gout education, which will take into account factors such as the individuals level of pre existing knowledge, and educational background.
Patients will receive a p
Person centred structured educational intervention (PC-SEV): Two home visits (at weeks 2 and 6) of approximately 1 hour, will be undertaken to deliver individualised structured education focused around key messages that are determined a priori. A health professional ( nurse or pharmacist) will visit the patients home, and deliver gout education, which will take into account factors such as the individuals level of pre existing knowledge, and educational background. Patients will receive a personalised flare plan to follow during an acute attack of gout to avoid going to hospital. This will include developing an emergency management plan, which will be formulated by their physician, and take into account current medications, allergies, and volatility of their gout. They will also have access to a dedicated telephone service for advice from a rheumatologist, which they can call at their own discretion. A summary booklet, designed for this study, will be provided as an ongoing reminder of the discussion and key messages. A point of care serum urate will be measured during the home visit, and urate lowering therapy escalated according to a predefined dose escalation regimen, based on international recommendations (Khanna, D., Fitzgerald, J.D., Khanna, P.P., Bae, S., Singh, M.K., Neogi, T., Pillinger, M.H., Merill, J., Lee, S., Prakash, S., Kaldas, M., Gogia, M., Perez-Ruiz, F., Taylor, W., Lioté, F., Choi, H., Singh, J.A., Dalbeth, N., Kaplan, S., Niyyar, V., Jones, D., Yarows, S.A., Roessler, B., Kerr, G., King, C., Levy, G., Furst, D.E., Edwards, N.L., Mandell, B., Schumacher, H.R., Robbins, M., Wenger, N. and Terkeltaub, R. (2012), 2012 American College of Rheumatology guidelines for management of gout. Part 1: Systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia. Arthritis Care Res, 64: 1431-1446.) Fall in serum urate will be used as a surrogate of compliance. The duration of the study is 16 weeks.
Sponsors
South Metropolitan Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Gout, meeting 2016 ACR classification criteria English literate Able to commit to study for 4 months Males over 18 years of age, or post menopausal females Residing in Australia
Exclusion criteria
Non-independent living Inability to give informed consent Any condition in the opinion of the investigator that should exclude the participant. Incarceration Intolerant of allopurinol and feboxustat
Outcome results
None listed