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Completed

NCT Number: NCT01549210

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

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.

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Key information

Conditions

Gout Arthritis Arthritis, Gouty Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept of Rheumatology - IRCCS San Matteo Foundation

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Functional disability

    Time frame: 1 year

    Health Assessment Questionnaire Disability Index (HAQ-DI)

Secondary outcomes

  1. Health-related quality of life

    Time frame: 1 year

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

Other outcomes

  1. Short Form-36 Mental Summary Scale (SF-36 MCS)

    Time frame: 1 year

  2. Serum uric acid levels

    Time frame: 6-12 months

Sponsors and collaborators

Lead sponsor

Italian Society for Rheumatology

Other

Registry information

Official study title

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

Acronym: KING

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 9, 2012
Registry last updated
Mar 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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