GoutNCT01418781
CLinical Prediction Rule Score in Veterans
An observational study of Gout, run by jasvinder singh at 1 site in United States.
Trial summary
We will study whether the health care costs and health utilities differ in patients with gout and those without gout and whether they differ between those with more severe versus less severe gout Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Gout
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Mar 2010
- 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 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with and without gout from the Veterans Upper Midwest SF-36 survey database will be included in the analyses for Study questions 1 and 5. This is approximately 3000 gout patients and 67,000 non-gout patients Patients with SF-36 data from the above cohort will be included in the analyses for Study aims 2-4. This is approximately 1500 gout patients and 38,000 non-gout patients
Who may be able to join
- participated in the survey
- Have SF-36 adn utilization data
Who cannot join
- Absence of utilization and/or cost data
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55123
About this study
Official title: Development of CLinical Prediction Rule Score in Veterans: A Study of Impact of Gout on Health Care Utilization and Costs
We will study whether the health care costs and health utilities differ in patients with gout and those without gout and whether they differ between those with more severe versus less severe gout
Read the detailed description
The purpose of this project is to study the out-patient and inpatient utilization and costs associated with tophaceous gout (a classic form of treatment-failure gout), compare these costs to patients with non-tophaceous gout and evaluate health utilities associated with these gout states. The analyses will be conducted in a manner to support a burden of illness type of presentation / manuscript.
Study Questions
- What are the VA health care costs (inpatient and outpatient) for patients with gout compared to those without gout?
- Does health utility, as calculated by SF-6D, differ in patients with gout compared to patients without gout and between tophaceous and non-tophaceous gout?
- What are the relationships between costs and health utility?
- How does the burden of illness differ by subgroups of gout patients (costs and utilities)?
- What are the VA health care costs for patients with tophaceous gout and are they higher than patients with non-tophaceous gout?
Inclusion criteria Patients with and without gout from the Veterans database described above will be included in the analyses for Study aims 1 and 5. This is approximately 3000 gout patients and 67,000 non-gout patients
Patients with SF-36 data from the above cohort will be included in the analyses for Study aims 2-4. This is approximately 1500 gout patients and 38,000 non-gout patients
- Conditions
- Gout
- Keywords
- gout, cost, utilization
- Medical subject headings
- Gout, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gout | Patients with ICD-9 for gout | |
| No Gout | Patients withOUT ICD-9 for gout | |
| Tophaceous gout | Patients with ICD-9 for tophaceous gout | |
| non-tophaceous gout | those with ICD-9 for gout other than the codes specific for tophaceous gout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health care costs
Total of outpatient, inpatient and emergent care costs
Measured: Up to 5-year post-survey
Secondary outcomes (4)
Health utility index, SF-6D
at 18-month post-survey
Measured: 18-months
Health care utilization
Health care utilization as sum of outpatient, inpatient and emergent care utilization
Measured: 1-year post-survey
Activity limitation on Katz 6 ADL
Katz 6 ADL questions assess difficulty with doing 6 key activities, bathing, eating, toileting, walking, getting up and climbing stairs
Measured: 18-months
Mortality
Up to 5-year post-survey
Measured: 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startJan 2008
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Funding withdrawn by the funding agency; study could not be performed.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- jasvinder singh
- Sponsor type
- US federal agency
- Collaborators
- Birmingham, Alabama VA Medical Center, Takeda, Novartis, Regeneron Pharmaceuticals
- Responsible party
- Sponsor-investigator, jasvinder singh, Minneapolis Veterans Affairs Medical Center
- Investigators
- David Nelson, Principal investigator, Minneapolis VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418781
- Sponsor's protocol ID
- MVAMC-3669A
- Status last verified
- Mar 2024
- First submitted
- 15 Aug 2011
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of CLinical Prediction Rule Score in Veterans: A Study of Impact of Gout on Health Care Utilization and Costs
- ClinicalTrials.gov ID
- NCT01418781
- Acronym / sponsor ID
- MVAMC-3669A
- Conditions
- Gout
- Keywords
- gout, cost, utilization
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding withdrawn by the funding agency; study could not be performed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- jasvinder singhUS federal agency
- Collaborators
- Birmingham, Alabama VA Medical Center, Takeda, Novartis, Regeneron Pharmaceuticals
- Study start
- Jan 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 17 Aug 2011 (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.
We will study whether the health care costs and health utilities differ in patients with gout and those without gout and whether they differ between those with more severe versus less severe gout
Detailed description
The purpose of this project is to study the out-patient and inpatient utilization and costs associated with tophaceous gout (a classic form of treatment-failure gout), compare these costs to patients with non-tophaceous gout and evaluate health utilities associated with these gout states. The analyses will be conducted in a manner to support a burden of illness type of presentation / manuscript.
Study Questions
- What are the VA health care costs (inpatient and outpatient) for patients with gout compared to those without gout?
- Does health utility, as calculated by SF-6D, differ in patients with gout compared to patients without gout and between tophaceous and non-tophaceous gout?
- What are the relationships between costs and health utility?
- How does the burden of illness differ by subgroups of gout patients (costs and utilities)?
- What are the VA health care costs for patients with tophaceous gout and are they higher than patients with non-tophaceous gout?
Inclusion criteria Patients with and without gout from the Veterans database described above will be included in the analyses for Study aims 1 and 5. This is approximately 3000 gout patients and 67,000 non-gout patients
Patients with SF-36 data from the above cohort will be included in the analyses for Study aims 2-4. This is approximately 1500 gout patients and 38,000 non-gout patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Gout | – | –Patients with ICD-9 for gout |
| No Gout | – | –Patients withOUT ICD-9 for gout |
| Tophaceous gout | – | –Patients with ICD-9 for tophaceous gout |
| non-tophaceous gout | – | –those with ICD-9 for gout other than the codes specific for tophaceous gout |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with and without gout from the Veterans Upper Midwest SF-36 survey database will be included in the analyses for Study questions 1 and 5. This is approximately 3000 gout patients and 67,000 non-gout patients Patients with SF-36 data from the above cohort will be included in the analyses for Study aims 2-4. This is approximately 1500 gout patients and 38,000 non-gout patients
Key inclusion criteria (2 listed)
- participated in the survey
- Have SF-36 adn utilization data
Key exclusion criteria (1 listed)
- Absence of utilization and/or cost data
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
Health care costs
Time frame: Up to 5-year post-survey
Total of outpatient, inpatient and emergent care costs
4 secondary outcomes
Health utility index, SF-6D
Time frame: 18-months
Health care utilization
Time frame: 1-year post-survey
Activity limitation on Katz 6 ADL
Time frame: 18-months
Mortality
Time frame: 5-years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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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.
David Nelson principal investigator
Minneapolis VAMC
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 jasvinder singh at 1 site in United States.
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 1 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: withdrawn, as of the sponsor's last update on 13 Mar 2024. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Health care costs (time frame: Up to 5-year post-survey). 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 13 Mar 2024.