NCT01549210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 12, 2013

Status Verified

March 1, 2013

Enrollment Period

1.9 years

First QC Date

March 6, 2012

Last Update Submit

March 9, 2013

Conditions

Gout

Keywords

goutgouty arthritis

Outcome Measures

Primary Outcomes (1)

  • Functional disability

    Health Assessment Questionnaire Disability Index (HAQ-DI)

    1 year

Secondary Outcomes (1)

  • Health-related quality of life

    1 year

Other Outcomes (2)

  • Short Form-36 Mental Summary Scale (SF-36 MCS)

    1 year

  • Serum uric acid levels

    6-12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients referring to rheumatologic clinics

You may qualify if:

  • Clinical diagnosis of gout
  • Must be able to understand questionnaires

You may not qualify if:

  • Diagnosis not validated by rheumatologist
  • Not able to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Rheumatology - IRCCS San Matteo Foundation

Pavia, Pavia, 27100, Italy

Location

MeSH Terms

Conditions

GoutArthritis, Gouty

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Carlo A Scirè, MD, PhD

    Epidemiology Unit - Italian Society for Rheumatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Coordinator of the Epidemiology Unit - SIR

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 9, 2012

Study Start

April 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 12, 2013

Record last verified: 2013-03

Locations

IT(1)