Arthritis Research UK Gout Treatment Trial - Phase 2
1 other identifier
interventional
517
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2011
CompletedFirst Posted
Study publicly available on registry
November 22, 2011
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJanuary 5, 2017
January 1, 2017
3.6 years
November 14, 2011
January 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in serum uric acid levels
2 years
Secondary Outcomes (2)
Reduction in number of self reported acute attacks during year 2
2 years
Improved Quality of Life scores at study end
2 years
Study Arms (2)
Nurse intervention
OTHERNurse led package of care based on current recommended best practice.
Standard care
OTHERContinuing standard general practitioner led care
Interventions
Complex package of care involving patient information and advice concerning lifestyle modification and recommended drug therapy.
Eligibility Criteria
You may qualify if:
- Diagnosis of gout
- At least one acute attack of gout within previous 12 months
You may not qualify if:
- \- Inability to give informed consent and known terminal or mental illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nottinghamlead
- Arthritis Research UKcollaborator
Study Sites (1)
Academic Rheumatology, University of Nottingham
Nottingham, NG5 1PB, United Kingdom
Related Publications (2)
Stamp LK, Frampton C, Morillon MB, Taylor WJ, Dalbeth N, Singh JA, Doherty M, Zhang W, Richardson H, Sarmanova A, Christensen R. Association between serum urate and flares in people with gout and evidence for surrogate status: a secondary analysis of two randomised controlled trials. Lancet Rheumatol. 2022 Jan;4(1):e53-e60. doi: 10.1016/S2665-9913(21)00319-2. Epub 2021 Nov 5.
PMID: 38288731DERIVEDDoherty 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.
PMID: 30343856DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Doherty, MA MD FRCP
University of Nottingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2011
First Posted
November 22, 2011
Study Start
March 1, 2013
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
January 5, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share