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Gout; HyperuricemiaNCT07061587

Developing A Gout Action Plan in Primary Care Setting in Singapore

A study testing Gout action plan in people with Gout; Hyperuricemia and Gout Flare, run by SingHealth Polyclinics at 1 site in Singapore.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Gout; Hyperuricemia, Gout Flare, Gout Chronic
What is being tested?
Gout action plan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteSingapore
Study dates
Aug 2025to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Currently still in clinical practice
  • Manage gout in their clinical practice

Who cannot join

  • Mental disorders
  • Cognitive impairment
  • Hearing and/ or speech impairments
  • Pregnant
  • Known terminal illness
  • Unable to provide informed consent
Show all 9Show fewer
  • For healthcare professionals:
  • Not involved in gout management in the practice
  • No longer in clinical practice

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Siew Lee Liew, Master of Family Medicine contact

+6593483312

liew.siew.lee@singhealth.com.sg

Singapore1 site
  • SingHealth Polyclinics

    Singapore

Other trials in Singapore

About this study

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:

Read more
  • 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.
Read the 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.

Being tested
Gout action plan
Keywords
Gout action plan, action plan
Medical subject headings
Gout, Hyperuricemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gout action planBehavioural

    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)

Study groups in NCT07061587
Study groupRoleWhat they receive
Control armNo interventionUsual clinical care for this arm. No intervention delivered.
Intervention armActive comparatorPatients in intervention arm will receive gout action plan on top of usual clinical care.
Receives: Behavioral: Gout action plan

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

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

Secondary outcomes (5)
  1. Change from baseline in the number of gout flares at 6 months

    patient self-reported gout flares or visit to healthcare professionals for gout flares

    Measured: from enrolment to the end of intervention at 6 months

  2. Change of serum uric acid level from baseline at 6 months

    serum uric level will be measured via laboratory test

    Measured: from enrolment to end of intervention at 6 months

  3. change from baseline in health-related quality of life 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

    Measured: from enrolment to the end of intervention at 6 months

  4. Numbers of participants consented to join the study among those approached (participation rate)

    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

    Measured: from enrolment to end of intervention at 6 months

  5. number of participants drop out of study (dropout rate)

    dropout rate will be counted by looking at number of participants drop out of the study compared to number of participants consented

    Measured: from enrolment to end of intervention at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2025
  2. Study startAug 2025 (estimated)
  3. Primary completionMay 2026 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will employ a sequential mixed-method design, which comprises of: 1. Qualitative research to develop and refine prototype of gout action plan by gathering perspectives from both patients and healthcare providers. 2. An open label pilot RCT to assess feasibility and estimate effectiveness of gout action plan in reducing gout flares, improvement in uric acid and quality of life.
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07061587
Sponsor's protocol ID
2025-0162
Status last verified
Jul 2025
First submitted
2 Jul 2025
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Sivasegaran S, Hanafi NSH. Perceptions and practices of self-management among adult patients with gout at a primary care clinic: A qualitative study. Malays Fam Physician. 2023 Dec 18;18:72. doi: 10.51866/oa.428. eCollection 2023.

    PubMed 38213387
  • Hodkinson A, Bower P, Grigoroglou C, Zghebi SS, Pinnock H, Kontopantelis E, Panagioti M. Self-management interventions to reduce healthcare use and improve quality of life among patients with asthma: systematic review and network meta-analysis. BMJ. 2020 Aug 18;370:m2521. doi: 10.1136/bmj.m2521.

    PubMed 32816816
  • Gibson PG, Powell H, Coughlan J, Wilson AJ, Abramson M, Haywood P, Bauman A, Hensley MJ, Walters EH. Self-management education and regular practitioner review for adults with asthma. Cochrane Database Syst Rev. 2003;(1):CD001117. doi: 10.1002/14651858.CD001117.

    PubMed 12535399
  • Tan FCJH, Oka P, Dambha-Miller H, Tan NC. The association between self-efficacy and self-care in essential hypertension: a systematic review. BMC Fam Pract. 2021 Feb 22;22(1):44. doi: 10.1186/s12875-021-01391-2.

    PubMed 33618661
  • Allegrante JP, Wells MT, Peterson JC. Interventions to Support Behavioral Self-Management of Chronic Diseases. Annu Rev Public Health. 2019 Apr 1;40:127-146. doi: 10.1146/annurev-publhealth-040218-044008. Epub 2019 Jan 2.

    PubMed 30601717
  • Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.

    PubMed 12867348
  • Spragg JCJ, Michael TJF, Aslani P, Coleshill MJ, Chan JS, Day RO, Stocker SL. Optimizing adherence to allopurinol for gout: patients' perspectives. Br J Clin Pharmacol. 2023 Jul;89(7):1978-1991. doi: 10.1111/bcp.15657. Epub 2023 Jan 25.

    PubMed 36607199
  • Yin R, Li L, Zhang G, Cui Y, Zhang L, Zhang Q, Fu T, Cao H, Li L, Gu Z. Rate of adherence to urate-lowering therapy among patients with gout: a systematic review and meta-analysis. BMJ Open. 2018 Apr 10;8(4):e017542. doi: 10.1136/bmjopen-2017-017542.

    PubMed 29643150
  • Liddle J, Richardson JC, Hider SL, Mallen CD, Watson L, Chandratre P, Roddy E. 'It's just a great muddle when it comes to food': a qualitative exploration of patient decision-making around diet and gout. Rheumatol Adv Pract. 2021 Aug 13;5(3):rkab055. doi: 10.1093/rap/rkab055. eCollection 2021.

    PubMed 34514294
  • Chin A, Adams RJ, Gill TK, Hill CL. Gout Knowledge: A Survey of Australian Outpatients with Gout. Open Access Rheumatol. 2024 Jan 13;16:1-7. doi: 10.2147/OARRR.S435692. eCollection 2024.

    PubMed 38239283
  • Harrold LR, Mazor KM, Peterson D, Naz N, Firneno C, Yood RA. Patients' knowledge and beliefs concerning gout and its treatment: a population based study. BMC Musculoskelet Disord. 2012 Sep 21;13:180. doi: 10.1186/1471-2474-13-180.

    PubMed 22995041
  • Li R, Yu K, Li C. Dietary factors and risk of gout and hyperuricemia: a meta-analysis and systematic review. Asia Pac J Clin Nutr. 2018;27(6):1344-1356. doi: 10.6133/apjcn.201811_27(6).0022.

    PubMed 30485934
  • Rainer TH, Cheng CH, Janssens HJ, Man CY, Tam LS, Choi YF, Yau WH, Lee KH, Graham CA. Oral Prednisolone in the Treatment of Acute Gout: A Pragmatic, Multicenter, Double-Blind, Randomized Trial. Ann Intern Med. 2016 Apr 5;164(7):464-71. doi: 10.7326/M14-2070. Epub 2016 Feb 23.

    PubMed 26903390
  • Sanchez-Borges M, Caballero-Fonseca F, Capriles-Hulett A, Gonzalez-Aveledo L. Hypersensitivity Reactions to Nonsteroidal Anti-Inflammatory Drugs: An Update. Pharmaceuticals (Basel). 2010 Jan 5;3(1):10-18. doi: 10.3390/ph3010010.

    PubMed 27713240
  • Harirforoosh S, Asghar W, Jamali F. Adverse effects of nonsteroidal antiinflammatory drugs: an update of gastrointestinal, cardiovascular and renal complications. J Pharm Pharm Sci. 2013;16(5):821-47. doi: 10.18433/j3vw2f.

    PubMed 24393558

Questions about this trial

What is this clinical trial studying?

A study testing Gout action plan in people with Gout; Hyperuricemia and Gout Flare, run by SingHealth Polyclinics at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Siew Lee Liew, Master of Family Medicine (+6593483312, liew.siew.lee@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07061587, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.

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