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
  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014