Italian Observational Study Assessing the Impact of Gout on Patients Disability and Quality of Life

Gout Clinical Trial

— KING  

Official title:

Multicentre Prospective Observational Study for Identification of Determinants of Disability and Quality of Life in Patients With Gout.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549210
• Other study ID #: SIR-2011\OSS001
• Status: Completed
• Phase: N/A
• First received: March 6, 2012
• Last updated: March 9, 2013
• Start date: April 2011
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: Italian Society for Rheumatology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The study aims to identify which characteristics are associated with disability and poor quality of life in patients suffering from gout. This is a multicentre prospective observational study carried out in a cohort of Italian patients with gout. Subjects are randomly selected from a list of patients referred to each participant rheumatology clinic in the previous 2 years. Clinical evaluations are performed at baseline, at 6 and 12 months; data are retrieved about sociodemographic variables, life-styles, history of gout, comorbidities and patterns of treatment. At each visit patients complete questionnaires assessing disability and health-related quality of life. Preplanned analyses will be performed to investigate predictors of disability and poor quality of life in these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of gout

• Must be able to understand questionnaires

Exclusion Criteria:

• Diagnosis not validated by rheumatologist

• Not able to sign informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gout

Locations

Country	Name	City	State
Italy	Dept of Rheumatology - IRCCS San Matteo Foundation	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Italian Society for Rheumatology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Short Form-36 Mental Summary Scale (SF-36 MCS)		1 year	No
Other	Serum uric acid levels		6-12 months	No
Primary	Functional disability	Health Assessment Questionnaire Disability Index (HAQ-DI)	1 year	No
Secondary	Health-related quality of life	Short Form-36 Physical Summary Scale (SF-36 PCS)	1 year	No