This trial is active, not recruiting.

Condition gout
Treatments nurse intervention, standard care
Sponsor University of Nottingham
Collaborator Arthritis Research UK
Start date March 2013
End date October 2016
Trial size 517 participants
Trial identifier NCT01477346, 11115


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Nurse led package of care based on current recommended best practice.
nurse intervention
Complex package of care involving patient information and advice concerning lifestyle modification and recommended drug therapy.
Continuing standard general practitioner led care
standard care
Continuing standard General Practitioner led care.

Primary Outcomes

Reduction in serum uric acid levels
time frame: 2 years

Secondary Outcomes

Reduction in number of self reported acute attacks during year 2
time frame: 2 years
Improved Quality of Life scores at study end
time frame: 2 years

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Arthritis Research UK Gout Treatment Trial. Phase 2: Two Year Randomised Controlled Trial of a Nurse Led Package of Care
Principal investigator Michael Doherty, MA MD FRCP
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Nottingham.