Italian Observational Study Assessing the Impact of Gout on Patients Disability and Quality of Life
- Conditions
- Gout
- Registration Number
- NCT01549210
- Lead Sponsor
- Italian Society for Rheumatology
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
- Clinical diagnosis of gout
- Must be able to understand questionnaires
- Diagnosis not validated by rheumatologist
- Not able to sign informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional disability 1 year Health Assessment Questionnaire Disability Index (HAQ-DI)
- Secondary Outcome Measures
Name Time Method Health-related quality of life 1 year Short Form-36 Physical Summary Scale (SF-36 PCS)
Trial Locations
- Locations (1)
Dept of Rheumatology - IRCCS San Matteo Foundation
🇮🇹Pavia, Italy