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The goal of this clinical trial is to develop a gout action plan in primary care setting in Singapore among adult patients with gout, and to learn if the gout action plan can improve gout control.
The main questions it aims to answer are:
Researchers will compare gout action plan to usual clinical care to see whether gout action plan helps in improving gout control.
Participants in intervention arm will be:
Full description
Gout is a common inflammatory arthritis often seen in primary care. Worldwide prevalence ranges from under 1% to 6.8%.(1) The prevalence of gout has risen over the past three decades, accompanied by an increase in morbidity. (2) In Singapore, prevalence of gout is 4.1% amongst the Singapore Chinese population.(3) Gout is associated with significant morbidity and mortality due to coronary heart disease and kidney disease(3), and has substantial burden and impact in quality of life, with higher healthcare utilization and high unemployment rate observed in middle aged men with gout. (4)
Patients with poorly controlled gout suffer from frequent gout flares, with acute onset of joint pain and swelling, affecting health-related quality of life.(5) A meta-synthesis showed that gout flares impact on patients' lives, including physical, psychological, social and family life. (6) In a primary care institution in Singapore, 28.2% of patients with gout had poorly controlled disease.(7) In a rheumatology clinic in Singapore, 33% of patients with gout visited emergency department at least once for gout flare, while 19.5% had at least one hospitalization for gout.(4)
Acute gout flares can be mitigated by pharmacotherapy. Timely administration of acute medications is important to alleviate the pain leading to early resolution of symptoms. American College of Rheumatology (ACR) Guideline 2020 (8) and European League Against Rheumatism (EULAR) 2016 (9) recommend colchicine, non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroid for treatment of acute gout flare. In primary care clinics in Singapore, colchicine was often prescribed for an acute gout flare.(7) However, colchicine has gastrointestinal side effects such as vomiting and diarrhea (10), and some patients are not aware of its side effects and exceeded prescribed dose. (10) NSAIDs might improve the pain if given within 24 hours. (11) However, NSAIDs are associated with gastrointestinal, renal and cardiovascular adverse effects, thus they may not be the suitable pharmacotherapy for those with renal, gastrointestinal or cardiovascular comorbidities. (12) NSAIDs also cause hypersensitivity reactions with estimated prevalence of hypersensitivity to NSAIDs to be 0.5 to 1.9% of the general population. (13) For patients who are unable to tolerate NSAIDs or colchicine, or have chronic renal disease, systemic corticosteroid such as oral prednisolone might be a good alternative as it provides similar improvement in pain relief. (11,14)
Aside to pharmacotherapy, dietary control is important to prevent gout flares. ACG guideline 2020 (8) includes conditional recommendations to reduce alcohol intake, adopt a low-purine diet, and prioritize weight loss. A meta-analysis showed that red meat, seafood, alcohol, fructose or sweetened soft drinks increase risk of gout and hyperuricemia, while consumption of soy foods, dairy products and vegetables reduce risk of gout. (15) However, there is lack of awareness in dietary triggers especially in those with active gout. (16) A recent study in Australia found that patients with gout lack knowledge about the risk and protective factors of gout. (17) Patients resisted dietary changes due to the restrictive nature of the diet, lack of resources for information, and perceived it as unrealistic and unmanageable. (18 )
Gout control remains suboptimal despite established guideline. Urate lowering therapy (ULT) remains the key in gout management and its initiation is recommended for patients with recurrent gout flares with treat-to-target strategy. (8) However, in primary care institution in Singapore, it was found that half of the patients with poorly controlled gout were not prescribed urate lowering therapy.(7) In patients with gout, the overall adherence rate to ULT is as low as 47%.(19) Patients with gout demonstrate poor adherence to urate lowering therapy as they have limited knowledge of gout and its treatment, their attitude and perception towards taking long term medications. Some patients avoid ULT due to fear of side effects or flares during initiation, leading to nonadherence. (20)
Self-management is important in the management of chronic diseases. (21) Interventions of self-management have been shown to improve self-efficacy, health behavior, subsequently improving health status and quality of life and reducing healthcare utilization. (22) Self-efficacy refers to an individual's belief in their capacity to execute behaviors necessary to produce specific performance attainments, and it is correlated with self-care. Raising self-efficacy is important to change behavior in self-care. (23)
An action plan is a patient-held guide to support self-management with educational value. In chronic diseases such as asthma, the action plan provides information on how to manage the disease on a day-to-day basis and has proven to encourage self-management, improve health outcomes and quality of life, and reduce unscheduled visits to physicians. (24,25) Likewise, gout is a chronic condition with acute gout flares intermittently, that will benefit from self-management. In a study in Malaysia, patients were capable in self-management of gout but to variable extent, some practice diet control, some use painkillers during acute gout attacks, some use traditional medicine rather than taking allopurinol, some use exercise or stress-reducing activities, and the type of self-management might be influenced by cultural and social factors. (26)
To our knowledge, there is no well recognized gout action plan. A gout action plan has not been subjected to prior development in terms of content, design and acceptability. We hope that by developing a gout action plan, it will give information to patients about the disease to raise knowledge on gout, to reduce frequency of exacerbation via dietary control and lifestyle measures, to provide information on pain relief medications and the risks of taking painkiller, and urate lowering therapy for those with recurrent gout flares, and safety-netting advice on when to seek help. The study thus aims to develop a prototype of gout action plan by incorporating patients' and primary care physicians' perspectives, hoping to improve quality of life and healthcare utilization among patients with gout.
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For patient participants:
Inclusion Criteria:
Exclusion Criteria:
For healthcare professionals:
Inclusion Criteria (for healthcare professionals):
Exclusion Criteria (for healthcare professionals):
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72 participants in 2 patient groups
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Central trial contact
Siew Lee Liew, Master of Family Medicine
Data sourced from clinicaltrials.gov
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