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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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.

Detailed Summary:
Sponsor: Italian Society for Rheumatology

Current Primary Outcome: Functional disability [ Time Frame: 1 year ]

Health Assessment Questionnaire Disability Index (HAQ-DI)


Original Primary Outcome: Same as current

Current Secondary Outcome: Health-related quality of life [ Time Frame: 1 year ]

Short Form-36 Physical Summary Scale (SF-36 PCS)


Original Secondary Outcome: Health-related quality of life [ Time Frame: 1 year ]

SF-36


Information By: Italian Society for Rheumatology

Dates:
Date Received: March 6, 2012
Date Started: April 2011
Date Completion:
Last Updated: March 9, 2013
Last Verified: March 2013