Primary Research Questions: 1. What is the frequency of self-reported gout attacks of patients diagnosed with gout in general practice?2. What is the prevalence of tophi in patients diagnosed with gout in general practice?3. Does the use of…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoints are the frequency of gout attacks, the presence of
tophi and the use of Allopurinol. The presence of gout will be validated
according to the ACR-EULAR 2015 criteria for gout and the gout calculator. The
frequency and characteristics of gout attacks will be measured using the
modified Gout Assessment Questionnaire 2.0. The presence and burden of tophi
will be measured using the validated Tophus Impact Questionnaire (TIQ-20). The
use of allopurinol will be ascertained using the Brief Medication
Questionnaire.
Secondary outcome
1. Demographics measured at baseline using questions derived from the Medical
Consumption Questionnaire.
2. Tests include the following laboratory examinations: estimated glomerular
filtration rate (eGFR), uric acid level, total cholesterol, low- and
high-density-lipoproteïne cholesterol and glucose (fasting). Therefore, at
baseline a single venapunction will take place at baseline. Blood pressure will
be measured once at baseline.
3. Clinical factors: Comorbidity will be assessed at baseline, 1 year and 2
years FU using the Self-Administered Comorbidity Questionnaire. For calculating
BMI, at baseline the patients length and weight will be asked. Physical and
mental health will be determined at baseline, 1 year and 2 years using the
SF-36 physical and mental component summary [18] and quality of life via the
EQ-5D.
4. Medication: The use and adherence to allopurinol and other gout-medication
will be evaluated every 3 months. The adherence to prescribed medication and
over the counter medication will be measured at baseline, 1 year and 2 years
follow-up using a derived version of the Brief Medication Questionnaire.
5. Diet and lifestyle: Dietary intake (consumption of fructose-rich and
carbonated beverages, alcohol, purine rich food, lactose and dairy products)
will be measured using the Dutch validated Food Frequency Questionnaire, at
baseline, 1 and 2 years follow-up. Physical activity will be measured at
baseline and hereafter every 6 months with the International physical activity
questionnaire. Smoking status will be asked at baseline, 1 year and 2 years
follow-up.
Background summary
In the Netherlands, 90% of the patients with gout are managed by GPs but most
research has been done in secondary care. In primary care there are questions
on the clinical relevance of long-term uric acid lowering treatment of gout. It
is also unclear whether factors such as diet, overweight and use of medication
might be associated with gout attack frequency.
Study objective
Primary Research Questions:
1. What is the frequency of self-reported gout attacks of patients diagnosed
with gout in general practice?
2. What is the prevalence of tophi in patients diagnosed with gout in general
practice?
3. Does the use of allopurinol decrease the self-reported gout attack frequency
in patients diagnosed with gout in general practice?
4. Does the use of allopurinol decrease the presence of tophi in patients
diagnosed with gout in general practice?
Secondary Research Questions:
5. Are patient characteristics and lifestyle factors (presence of
cardiovascular risk factors, BMI, smoking status, physical activity, social
status) associated with the frequency of gout attacks in patients diagnosed
with gout in general practice?
6. Is the consumption of fructose rich beverages, carbonated beverages,
alcohol, purine rich food, lactose and dairy products associated with the
frequency of gout attacks in patients diagnosed with gout in general practice?
7. Is the use of medication, such as diuretics and salicylates, associated with
the frequency of gout attacks in patients diagnosed with gout in general
practice?
Study design
prospective observational cohort study
Study burden and risks
The burden will be minimal for patients participating in this study. Patients
will visit their GP once for blood pressure measurement, measurement of weight
and length and for collecting the blood sample. The patient fills out 12
questionnaires which takes some time (30 min); Physical and psychological
discomfort will be minimal, since the questionnaires will mostly assess diet,
medication use and physical comorbidities.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- Age: older than 18 years.
- Contacted their GP with a gout attack in the year 2013, 2014 or 2015
Exclusion criteria
- Patients with a limited life expectancy.
- Patients that are not able (independently or with help) to fill in the Dutch questionnaires.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57154.078.16 |