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

March 9, 2013 updated by: Carlo Alberto Scire, Italian Society for Rheumatology

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Dept of Rheumatology - IRCCS San Matteo Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients referring to rheumatologic clinics

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional disability
Time Frame: 1 year
Health Assessment Questionnaire Disability Index (HAQ-DI)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life
Time Frame: 1 year
Short Form-36 Physical Summary Scale (SF-36 PCS)
1 year

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Italian Society for Rheumatology

Investigators

  • Principal Investigator: Carlo A Scirè, MD, PhD, Epidemiology Unit - Italian Society for Rheumatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

March 6, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (Estimate)

March 9, 2012

Study Record Updates

Last Update Posted (Estimate)

March 12, 2013

Last Update Submitted That Met QC Criteria

March 9, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIR-2011\OSS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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