Developing A Gout Action Plan in Primary Care Setting in Singapore
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorSingHealth Polyclinics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Mental disorders
Cognitive impairment
Hearing and/ or speech impairments
Pregnant
Trial design
Design model
Parallel
Treatments tested in this trial
Gout action plan
BehavioralGout 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)
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Control armNo intervention 0 interventions
Group B: Intervention armActive comparator 1 intervention
Trial outcomes
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.
Time frame
from enrolment to the end of in-depth interviews or focus group discussions at 6 monthsSecondary outcomes
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
Time frame
from enrolment to the end of intervention at 6 months2
Change of serum uric acid level from baseline at 6 months
serum uric level will be measured via laboratory test
Time frame
from enrolment to end of intervention at 6 months3
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
Time frame
from enrolment to the end of intervention at 6 months4
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
Time frame
from enrolment to end of intervention at 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: