Developing A Gout Action Plan in Primary Care Setting in Singapore

July 2, 2025 updated by: Liew Siew Lee, SingHealth Polyclinics

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore
        • SingHealth Polyclinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Exclusion Criteria:

  • Mental disorders
  • Cognitive impairment
  • Hearing and/ or speech impairments
  • Pregnant
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control arm
Usual clinical care for this arm. No intervention delivered.
Active Comparator: Intervention arm
Patients in intervention arm will receive gout action plan on top of usual clinical care.
Behavioral: Gout action plan
Gout action plan (that we aim to develop and refine during the study based on traffic light color system which will be categorized into zone system- green zone (well controlled), yellow zone (mild symptoms), red zone (severe symptoms). It will outline how to manage gout, identifying triggers, recognizing symptoms, appropriate medication usage, and when to seek medical attention)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Creation of a gout action plan in primary care setting in Singapore
Time Frame: 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.
from enrolment to the end of in-depth interviews or focus group discussions at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the number of gout flares at 6 months
Time Frame: from enrolment to the end of intervention at 6 months
patient self-reported gout flares or visit to healthcare professionals for gout flares
from enrolment to the end of intervention at 6 months
Change of serum uric acid level from baseline at 6 months
Time Frame: from enrolment to end of intervention at 6 months
serum uric level will be measured via laboratory test
from enrolment to end of intervention at 6 months
change from baseline in health-related quality of life at 6 months
Time Frame: from enrolment to the end of intervention at 6 months
participants achieved good quality of life on a scale ranging from 0 (worse quality of life) to 100 (best quality of life) using EQ-5D-5L questionnaire on health-related quality of life
from enrolment to the end of intervention at 6 months
Numbers of participants consented to join the study among those approached (participation rate)
Time Frame: from enrolment to end of intervention at 6 months
participation rate will be counted at looking at proportion of participants consented to join the study compared to total number of participants approached to join the study
from enrolment to end of intervention at 6 months
number of participants drop out of study (dropout rate)
Time Frame: from enrolment to end of intervention at 6 months
dropout rate will be counted by looking at number of participants drop out of the study compared to number of participants consented
from enrolment to end of intervention at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SingHealth Polyclinics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

July 2, 2025

First Submitted That Met QC Criteria

July 2, 2025

First Posted (Actual)

July 11, 2025

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-0162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared as gout action plan is still yet to be developed and the study will firstly started with qualitative research to refine the prototype of gout action plan.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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