Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001177640
Ethics application status
Approved
Date submitted
1/10/2014
Date registered
10/11/2014
Date last updated
7/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a package of care on outcomes in patients with gout
Scientific title
Effect of a package of care on serum urate levels in gout patients in a rural general practice setting
Secondary ID [1] 285426 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 293185 0
Condition category
Condition code
Musculoskeletal 293459 293459 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 293640 293640 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with gout receive a package of care from the GP which represents best clinical practice (based on ACR and EULAR guidelines). This will include
1. medication for acute gout as well as long term urate lowering therapy - this may be no different from the historical controls other than more focus on achieving appropriate treatment targets
2. education about the causes and management of gout - unknown what the controls received
3. screening for co-morbidities associated with gout including heart disease, diabetes and kidney disease - unknown what the controls received.
There is no specified treatment period as this is individualised The only proceedures outside of nornal clinical practice are that we will monitor whether patients take allopurinol (one form of urate lowering medication) through blood tests.
Intervention code [1] 290351 0
Not applicable
Comparator / control treatment
Will will compare outcomes with retrospective data from the same medical practice. Treatment in the historical control group was at the discretion of the treating general practitioner. The audit will determine how appropriate and successful this was. Historical data will be collected from 1/1/2012-31/12/2012 -
Control group
Historical

Outcomes
Primary outcome [1] 293278 0
Number of patients on urate lowering therapy from medication records and though blood tests
Timepoint [1] 293278 0
12 months
Primary outcome [2] 293279 0
Number of patients with serum urate <0.36mmol/l
Timepoint [2] 293279 0
12 months
Secondary outcome [1] 310705 0
Number of gout patients screened for comorbidities associated with gout from medical records
Timepoint [1] 310705 0
12 months

Eligibility
Key inclusion criteria
Gout
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwilling to provide consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/11/2014
Actual
5/01/2015
Date of last participant enrolment
Anticipated
Actual
6/10/2015
Date of last data collection
Anticipated
15/09/2016
Actual
31/12/2016
Sample size
Target
90
Accrual to date
Final
68
Recruitment outside Australia
Country [1] 6386 0
New Zealand
State/province [1] 6386 0
Canterbury

Funding & Sponsors
Funding source category [1] 290031 0
Government body
Name [1] 290031 0
Health Research Council of New Zealand
Country [1] 290031 0
New Zealand
Funding source category [2] 290032 0
Hospital
Name [2] 290032 0
Canterbury District Health Board
Country [2] 290032 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
POBox 4345
Christchurch 8014
Country
New Zealand
Secondary sponsor category [1] 288723 0
None
Name [1] 288723 0
Address [1] 288723 0
Country [1] 288723 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291738 0
Health and Disability Ethics Committee of New Zealand
Ethics committee address [1] 291738 0
PO Box 5013
Wellington 6011
Ethics committee country [1] 291738 0
New Zealand
Date submitted for ethics approval [1] 291738 0
05/10/2014
Approval date [1] 291738 0
28/10/2014
Ethics approval number [1] 291738 0
14/CEN/163

Summary
Brief summary
Gout is a common problem particularly in New Zealand. The majority of patients with gout are managed in primary care. Guidelines for management are well established and there are effective medications to prevent gout, but few patients achieve treatment targets, leading to painful gout attacks and eventual joint damage. We have implemented an integrated package of care, designed to be delivered in general practice that incorporates education, gout treatment and appropriate screening and management of important co-morbidities associated with gout such as heart disease and diabetes. Herein we will examine the effetcs of the package of care in a rural general practice setting, Kaikoura. We will determine whether more patients reach treatment targets and are screened for and where appropriate receive treatment for co-morbidities. Outcomes will be compared to retrospective data from the same medical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51810 0
Prof Lisa Stamp
Address 51810 0
POBox 4345
University of Otago, Christchurch
Christchurch 8014
Country 51810 0
New Zealand
Phone 51810 0
+ 64 3 364 0253
Fax 51810 0
Email 51810 0
[email protected]
Contact person for public queries
Name 51811 0
Prof Lisa Stamp
Address 51811 0
POBox 4345
University of Otago, Christchurch
Christchurch 8014
Country 51811 0
New Zealand
Phone 51811 0
+ 64 3 364 0253
Fax 51811 0
Email 51811 0
[email protected]
Contact person for scientific queries
Name 51812 0
Prof Lisa Stamp
Address 51812 0
POBox 4345
University of Otago, Christchurch
Christchurch 8014
Country 51812 0
New Zealand
Phone 51812 0
+ 64 3 364 0253
Fax 51812 0
Email 51812 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.