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临床试验/NCT07061587
NCT07061587尚未招募不适用

Developing A Gout Action Plan in Primary Care Setting in Singapore

SingHealth Polyclinics1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
72
试验地点
1
主要终点
Creation of a gout action plan in primary care setting in Singapore

研究概览

简要总结

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:

  • How do we develop a gout action plan in primary care setting in Singapore?
  • What is the feasibility and estimate effectiveness of the developed gout action plan?
  • Does gout action plan reduce frequency of gout flares in patients with gout?

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:

  • given gout action plan and follow up for a course of 6 months
  • asked to keep track of their gout symptoms
  • follow up on the number of gout flares they have.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For patient participants:
  • Inclusion Criteria:
  • Adults who are 21 years old and above
  • Clinical diagnosis of gout as per ACE-EULAR 2015 criteria
  • Had at least an episode of gout exacerbation within the last 1 year
  • Able to speak and read English
  • Singapore citizens or permanent residents
  • Able to provide informed consent

排除标准

  • Mental disorders
  • Cognitive impairment
  • Hearing and/ or speech impairments
  • Known terminal illness
  • Unable to provide informed consent
  • For healthcare professionals:
  • Inclusion Criteria (for healthcare professionals):
  • Currently still in clinical practice
  • Manage gout in their clinical practice
  • Exclusion Criteria (for healthcare professionals):
  • Not involved in gout management in the practice
  • No longer in clinical practice

结局指标

主要结局

Creation of a gout action plan in primary care setting in Singapore

时间窗: from enrolment to the end of in-depth interviews or focus group discussions at 6 months

in-depth interviews or focus group discussions to develop and refine prototype of gout action plan by gathering perspectives from both patients and healthcare providers.

次要结局

  • Change from baseline in the number of gout flares at 6 months(from enrolment to the end of intervention at 6 months)
  • Change of serum uric acid level from baseline at 6 months(from enrolment to end of intervention at 6 months)
  • change from baseline in health-related quality of life at 6 months(from enrolment to the end of intervention at 6 months)
  • Numbers of participants consented to join the study among those approached (participation rate)(from enrolment to end of intervention at 6 months)
  • number of participants drop out of study (dropout rate)(from enrolment to end of intervention at 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liew Siew Lee

Family Physician

SingHealth Polyclinics

研究点 (1)

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