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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:
Information provided by (Responsible Party):
Carlo Alberto Scire, Italian Society for Rheumatology
ClinicalTrials.gov Identifier:
NCT01549210
First received: March 6, 2012
Last updated: March 9, 2013
Last verified: March 2013
History of Changes
  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:

MedlinePlus related topics: Gout
U.S. FDA Resources

Further study details as provided by Italian Society for Rheumatology:

Primary Outcome Measures:
  • Functional disability [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Health Assessment Questionnaire Disability Index (HAQ-DI)


Secondary Outcome Measures:
  • Health-related quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Serum uric acid levels [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 6, 2012
Last Updated: March 9, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Italian Society for Rheumatology:
gout
gouty arthritis

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

ClinicalTrials.gov processed this record on May 21, 2013