We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01549210
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : March 12, 2013
Sponsor:
Information provided by (Responsible Party):

March 6, 2012
March 9, 2012
March 12, 2013
April 2011
March 2013   (Final data collection date for primary outcome measure)
Functional disability [ Time Frame: 1 year ]
Health Assessment Questionnaire Disability Index (HAQ-DI)
Same as current
Complete list of historical versions of study NCT01549210 on ClinicalTrials.gov Archive Site
Health-related quality of life [ Time Frame: 1 year ]
Short Form-36 Physical Summary Scale (SF-36 PCS)
Health-related quality of life [ Time Frame: 1 year ]
SF-36
  • Short Form-36 Mental Summary Scale (SF-36 MCS) [ Time Frame: 1 year ]
  • Serum uric acid levels [ Time Frame: 6-12 months ]
Not Provided
 
Italian Observational Study Assessing the Impact of Gout on Patients Disability and Quality of Life
Multicentre Prospective Observational Study for Identification of Determinants of Disability and Quality of Life in Patients With Gout.
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients referring to rheumatologic clinics
Gout
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
March 2013
March 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01549210
SIR-2011\OSS001
Yes
Not Provided
Not Provided
Carlo Alberto Scire, Italian Society for Rheumatology
Italian Society for Rheumatology
Not Provided
Principal Investigator: Carlo A Scirè, MD, PhD Epidemiology Unit - Italian Society for Rheumatology
Italian Society for Rheumatology
March 2013