Arthritis Research UK Gout Treatment Trial - Phase 2

Gout Clinical Trial

Official title:

Arthritis Research UK Gout Treatment Trial. Phase 2: Two Year Randomised Controlled Trial of a Nurse Led Package of Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477346
• Other study ID #: 11115
• Status: Completed
• Phase: N/A
• First received: November 14, 2011
• Last updated: January 4, 2017
• Start date: March 2013
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 517
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout

Intervention

Other:
• Nurse intervention
Complex package of care involving patient information and advice concerning lifestyle modification and recommended drug therapy.
• Standard care
Continuing standard General Practitioner led care.

Locations

Country	Name	City	State
United Kingdom	Academic Rheumatology, University of Nottingham	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	Arthritis Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in serum uric acid levels		2 years	No
Secondary	Reduction in number of self reported acute attacks during year 2		2 years	No
Secondary	Improved Quality of Life scores at study end		2 years	No