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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Gout; Hyperuricemia, Gout Flare, Gout Chronic
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Gout action plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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.
- First posted11 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Gout; HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- SingHealth Polyclinics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liew Siew Lee, SingHealth Polyclinics
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 38213387Hodkinson 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 32816816Gibson 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 12535399Tan 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 33618661Allegrante 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 30601717Lorig 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 12867348Spragg 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 36607199Yin 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 29643150Liddle 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 34514294Chin 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 38239283Harrold 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 22995041Li 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 30485934Rainer 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 26903390Sanchez-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 27713240Harirforoosh 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing A Gout Action Plan in Primary Care Setting in Singapore
- ClinicalTrials.gov ID
- NCT07061587
- Acronym / sponsor ID
- 2025-0162
- Conditions
- Gout; Hyperuricemia, Gout Flare, Gout Chronic
- Keywords
- Gout action plan, action plan
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- SingHealth PolyclinicsUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Usual clinical care for this arm. No intervention delivered. |
| Intervention arm | Active comparator | Behavioral: Gout action planPatients in intervention arm will receive gout action plan on top of usual clinical care. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- Mental disorders
- Cognitive impairment
- Hearing and/ or speech impairments
- Pregnant
- Known terminal illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gout action planGout 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) | Behavioural | Intervention arm |
Primary outcome
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.
5 secondary outcomes
Change from baseline in the number of gout flares at 6 months
Time frame: 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
change from baseline in health-related quality of life at 6 months
Time frame: 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
number of participants drop out of study (dropout rate)
Time frame: from enrolment to end of intervention at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Results publication: PubMed 38213387Sivasegaran 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.
- Results publication: PubMed 32816816Hodkinson 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.
- Results publication: PubMed 12535399Gibson 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.
- Results publication: PubMed 33618661Tan 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.
- Results publication: PubMed 30601717Allegrante 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.
- Results publication: PubMed 12867348Lorig 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.
- Results publication: PubMed 36607199Spragg 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.
- Results publication: PubMed 29643150Yin 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.
- Results publication: PubMed 34514294Liddle 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.
- Results publication: PubMed 38239283Chin 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.
- Results publication: PubMed 22995041Harrold 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.
- Results publication: PubMed 30485934Li 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.