Developing A Gout Action Plan in Primary Care Setting in Singapore

NCT07061587 | Not Yet Recruiting

• 1 other identifier: 2025-0162
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gout; Hyperuricemia; Gout Flare; Gout Chronic

Keywords

Gout action plan; action plan

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• 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

Study Arms (2)

Control arm

NO INTERVENTION

Usual clinical care for this arm. No intervention delivered.

Intervention arm

ACTIVE COMPARATOR

Patients in intervention arm will receive gout action plan on top of usual clinical care.

Behavioral: Gout action plan

Interventions

Gout action plan BEHAVIORAL

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)

Intervention arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• SingHealth Polyclinics: lead

Study Sites (1)

SingHealth Polyclinics

Singapore, Singapore

Location

Related Publications (26)

• 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.

  PMID: 38213387 RESULT

• 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.

  PMID: 32816816 RESULT

• 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.

  PMID: 12535399 RESULT

• 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.

  PMID: 33618661 RESULT

• 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.

  PMID: 30601717 RESULT

• 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.

  PMID: 12867348 RESULT

• 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.

  PMID: 36607199 RESULT

• 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.

  PMID: 29643150 RESULT

• 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.

  PMID: 34514294 RESULT

• 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.

  PMID: 38239283 RESULT

• 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.

  PMID: 22995041 RESULT

• 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.

  PMID: 30485934 RESULT

• 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.

  PMID: 26903390 RESULT

• 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.

  PMID: 27713240 RESULT

• 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.

  PMID: 24393558 RESULT

• van Durme CM, Wechalekar MD, Landewe RB, Pardo Pardo J, Cyril S, van der Heijde D, Buchbinder R. Non-steroidal anti-inflammatory drugs for acute gout. Cochrane Database Syst Rev. 2021 Dec 9;12(12):CD010120. doi: 10.1002/14651858.CD010120.pub3.

  PMID: 34882311 RESULT

• Rebello C, Thomson M, Bassett-Clarke D, Martini N. Patient awareness, knowledge and use of colchicine: an exploratory qualitative study in the Counties Manukau region, Auckland, New Zealand. J Prim Health Care. 2016 Jun;8(2):140-8. doi: 10.1071/HC15023.

  PMID: 27477556 RESULT

• Richette P, Doherty M, Pascual E, Barskova V, Becce F, Castaneda-Sanabria J, Coyfish M, Guillo S, Jansen TL, Janssens H, Liote F, Mallen C, Nuki G, Perez-Ruiz F, Pimentao J, Punzi L, Pywell T, So A, Tausche AK, Uhlig T, Zavada J, Zhang W, Tubach F, Bardin T. 2016 updated EULAR evidence-based recommendations for the management of gout. Ann Rheum Dis. 2017 Jan;76(1):29-42. doi: 10.1136/annrheumdis-2016-209707. Epub 2016 Jul 25.

  PMID: 27457514 RESULT

• FitzGerald JD, Dalbeth N, Mikuls T, Brignardello-Petersen R, Guyatt G, Abeles AM, Gelber AC, Harrold LR, Khanna D, King C, Levy G, Libbey C, Mount D, Pillinger MH, Rosenthal A, Singh JA, Sims JE, Smith BJ, Wenger NS, Bae SS, Danve A, Khanna PP, Kim SC, Lenert A, Poon S, Qasim A, Sehra ST, Sharma TSK, Toprover M, Turgunbaev M, Zeng L, Zhang MA, Turner AS, Neogi T. 2020 American College of Rheumatology Guideline for the Management of Gout. Arthritis Care Res (Hoboken). 2020 Jun;72(6):744-760. doi: 10.1002/acr.24180. Epub 2020 May 11.

  PMID: 32391934 RESULT

• Oka P, Chong WM, Ng DX, Aau WK, Tan NC. Epidemiology and risk factors associated with gout control among adult Asians: a real-world retrospective cohort study. Front Med (Lausanne). 2023 Sep 7;10:1253839. doi: 10.3389/fmed.2023.1253839. eCollection 2023.

  PMID: 37746085 RESULT

• Stewart S, Guillen AG, Taylor WJ, Gaffo A, Slark J, Gott M, Dalbeth N. The experience of a gout flare: a meta-synthesis of qualitative studies. Semin Arthritis Rheum. 2020 Aug;50(4):805-811. doi: 10.1016/j.semarthrit.2020.06.001. Epub 2020 Jun 9.

  PMID: 32554059 RESULT

• Proudman C, Lester SE, Gonzalez-Chica DA, Gill TK, Dalbeth N, Hill CL. Gout, flares, and allopurinol use: a population-based study. Arthritis Res Ther. 2019 May 31;21(1):132. doi: 10.1186/s13075-019-1918-7.

  PMID: 31151457 RESULT

• Chua CKT, Cheung PP, Santosa A, Lim AYN, Teng GG. Burden and management of gout in a multi-ethnic Asian cohort. Rheumatol Int. 2020 Jul;40(7):1029-1035. doi: 10.1007/s00296-019-04475-6. Epub 2019 Nov 22.

  PMID: 31758246 RESULT

• Teng GG, Ang LW, Saag KG, Yu MC, Yuan JM, Koh WP. Mortality due to coronary heart disease and kidney disease among middle-aged and elderly men and women with gout in the Singapore Chinese Health Study. Ann Rheum Dis. 2012 Jun;71(6):924-8. doi: 10.1136/ard.2011.200523. Epub 2011 Dec 15.

  PMID: 22172492 RESULT

• He Q, Mok TN, Sin TH, Yin J, Li S, Yin Y, Ming WK, Feng B. Global, Regional, and National Prevalence of Gout From 1990 to 2019: Age-Period-Cohort Analysis With Future Burden Prediction. JMIR Public Health Surveill. 2023 Jun 7;9:e45943. doi: 10.2196/45943.

  PMID: 37285198 RESULT

• Dehlin M, Jacobsson L, Roddy E. Global epidemiology of gout: prevalence, incidence, treatment patterns and risk factors. Nat Rev Rheumatol. 2020 Jul;16(7):380-390. doi: 10.1038/s41584-020-0441-1. Epub 2020 Jun 15.

  PMID: 32541923 RESULT

MeSH Terms

Conditions

Gout; Hyperuricemia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Siew Lee Liew, Master of Family Medicine

CONTACT

+6593483312; liew.siew.lee@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Family Physician

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: August 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)