Back to resultsArthritis Research UK Gout Treatment Trial - Phase 2
Primary Purpose
Gout
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Nurse intervention
Standard care
Sponsored by
About this trial
This is an interventional treatment trial for Gout
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of gout
- At least one acute attack of gout within previous 12 months
Exclusion Criteria:
- Inability to give informed consent and known terminal or mental illness
Sites / Locations
- Academic Rheumatology, University of Nottingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Nurse intervention
Standard care
Arm Description
Nurse led package of care based on current recommended best practice.
Continuing standard general practitioner led care
Outcomes
Primary Outcome Measures
Reduction in serum uric acid levels
Secondary Outcome Measures
Reduction in number of self reported acute attacks during year 2
Improved Quality of Life scores at study end
Full Information
NCT ID
NCT01477346
First Posted
November 14, 2011
Last Updated
January 4, 2017
Sponsor
University of Nottingham
Collaborators
Arthritis Research UK
1. Study Identification
Unique Protocol Identification Number
NCT01477346
Brief Title
Arthritis Research UK Gout Treatment Trial - Phase 2
Official Title
Arthritis Research UK Gout Treatment Trial. Phase 2: Two Year Randomised Controlled Trial of a Nurse Led Package of Care
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
Arthritis Research UK
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine in community-derived patients with gout the effectiveness, and cost effectiveness, of a nurse-led complex intervention that reflects recommended best practice (including patient information concerning gout, its prognosis and its non-pharmacological and drug options).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
517 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nurse intervention
Arm Type
Other
Arm Description
Nurse led package of care based on current recommended best practice.
Arm Title
Standard care
Arm Type
Other
Arm Description
Continuing standard general practitioner led care
Intervention Type
Other
Intervention Name(s)
Nurse intervention
Intervention Description
Complex package of care involving patient information and advice concerning lifestyle modification and recommended drug therapy.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Continuing standard General Practitioner led care.
Primary Outcome Measure Information:
Title
Reduction in serum uric acid levels
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Reduction in number of self reported acute attacks during year 2
Time Frame
2 years
Title
Improved Quality of Life scores at study end
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of gout
At least one acute attack of gout within previous 12 months
Exclusion Criteria:
- Inability to give informed consent and known terminal or mental illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Doherty, MA MD FRCP
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Rheumatology, University of Nottingham
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30343856
Citation
Doherty M, Jenkins W, Richardson H, Sarmanova A, Abhishek A, Ashton D, Barclay C, Doherty S, Duley L, Hatton R, Rees F, Stevenson M, Zhang W. Efficacy and cost-effectiveness of nurse-led care involving education and engagement of patients and a treat-to-target urate-lowering strategy versus usual care for gout: a randomised controlled trial. Lancet. 2018 Oct 20;392(10156):1403-1412. doi: 10.1016/S0140-6736(18)32158-5.
Results Reference
derived
Learn more about this trial
Arthritis Research UK Gout Treatment Trial - Phase 2
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