GoutKINGNCT01549210
Italian Observational Study Assessing the Impact of Gout on Patients Disability and Quality of Life
An observational study of Gout, run by Italian Society for Rheumatology at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout
- How many people
- 450 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2011to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referring to rheumatologic clinics
Who may be able to join
- Clinical diagnosis of gout
- Must be able to understand questionnaires
Who cannot join
- Diagnosis not validated by rheumatologist
- Not able to sign informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dept of Rheumatology - IRCCS San Matteo Foundation
Pavia, Pavia, 27100
About this study
Official title: 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.
- Conditions
- Gout
- Keywords
- gout, gouty arthritis
- Medical subject headings
- Gout, Arthritis, Gouty
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional disability
Health Assessment Questionnaire Disability Index (HAQ-DI)
Measured: 1 year
Secondary outcomes (1)
Health-related quality of life
Short Form-36 Physical Summary Scale (SF-36 PCS)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startApr 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Italian Society for Rheumatology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Alberto Scire, Italian Society for Rheumatology
- Investigators
- Carlo A Scirè, MD, PhD, Principal investigator, Epidemiology Unit - Italian Society for Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549210
- Sponsor's protocol ID
- SIR-2011\OSS001
- Acronym
- KING
- Status last verified
- Mar 2013
- First submitted
- 6 Mar 2012
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Prospective Observational Study for Identification of Determinants of Disability and Quality of Life in Patients With Gout.
- ClinicalTrials.gov ID
- NCT01549210
- Acronym / sponsor ID
- KING / SIR-2011\OSS001
- Conditions
- Gout
- Keywords
- gout, gouty arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Italian Society for RheumatologyUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referring to rheumatologic clinics
Key inclusion criteria (2 listed)
- Clinical diagnosis of gout
- Must be able to understand questionnaires
Key exclusion criteria (2 listed)
- Diagnosis not validated by rheumatologist
- Not able to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional disability
Time frame: 1 year
Health Assessment Questionnaire Disability Index (HAQ-DI)
1 secondary outcome
Health-related quality of life
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo A Scirè, MD, PhD principal investigator
Epidemiology Unit - Italian Society for Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gout, run by Italian Society for Rheumatology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional disability (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2013.