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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01549210

Acronym

KING

Enrollment

450

Registered

2012-03-09

Start date

2011-04-30

Completion date

2013-03-31

Last updated

2013-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout

Keywords

gout, gouty arthritis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

Italy

Outcome results