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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01549210
First Posted: March 9, 2012
Last Update Posted: March 12, 2013
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.
Information provided by (Responsible Party):
Carlo Alberto Scire, Italian Society for Rheumatology
  Purpose
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.

Condition
Gout

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicentre Prospective Observational Study for Identification of Determinants of Disability and Quality of Life in Patients With Gout.

Resource links provided by NLM:


Further study details as provided by Carlo Alberto Scire, Italian Society for Rheumatology:

Primary Outcome Measures:
  • Functional disability [ Time Frame: 1 year ]
    Health Assessment Questionnaire Disability Index (HAQ-DI)


Secondary Outcome Measures:
  • Health-related quality of life [ Time Frame: 1 year ]
    Short Form-36 Physical Summary Scale (SF-36 PCS)


Other Outcome Measures:
  • Short Form-36 Mental Summary Scale (SF-36 MCS) [ Time Frame: 1 year ]
  • Serum uric acid levels [ Time Frame: 6-12 months ]

Enrollment: 450
Study Start Date: April 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients referring to rheumatologic clinics
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549210


Locations
Italy
Dept of Rheumatology - IRCCS San Matteo Foundation
Pavia, Italy, 27100
Sponsors and Collaborators
Italian Society for Rheumatology
Investigators
Principal Investigator: Carlo A Scirè, MD, PhD Epidemiology Unit - Italian Society for Rheumatology
  More Information

Responsible Party: Carlo Alberto Scire, MD, PhD, Coordinator of the Epidemiology Unit - SIR, Italian Society for Rheumatology
ClinicalTrials.gov Identifier: NCT01549210     History of Changes
Other Study ID Numbers: SIR-2011\OSS001
First Submitted: March 6, 2012
First Posted: March 9, 2012
Last Update Posted: March 12, 2013
Last Verified: March 2013

Keywords provided by Carlo Alberto Scire, Italian Society for Rheumatology:
gout
gouty arthritis

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases