Arthritis Research UK Gout Treatment Trial - Phase 2

This study is currently recruiting participants.
Verified January 2014 by University of Nottingham
Sponsor:
Collaborator:
Arthritis Research UK
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01477346
First received: November 14, 2011
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention
Gout
Other: Nurse intervention
Other: Standard care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Arthritis Research UK Gout Treatment Trial. Phase 2: Two Year Randomised Controlled Trial of a Nurse Led Package of Care

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Reduction in serum uric acid levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in number of self reported acute attacks during year 2 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Improved Quality of Life scores at study end [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 724
Study Start Date: March 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nurse intervention
Nurse led package of care based on current recommended best practice.
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
Other: Standard care
Continuing standard General Practitioner led care.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477346

Contacts
Contact: Helen Richardson, BA (Hons) 00 44 115 8231756 helen.richardson@nottingham.ac.uk

Locations
United Kingdom
Academic Rheumatology, University of Nottingham Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Helen Richardson, BA (Hons)    00 44 115 8231756    helen.richardson@nottingham.ac.uk   
Sponsors and Collaborators
University of Nottingham
Arthritis Research UK
Investigators
Principal Investigator: Michael Doherty, MA MD FRCP University of Nottingham
  More Information

No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01477346     History of Changes
Other Study ID Numbers: 19703
Study First Received: November 14, 2011
Last Updated: January 14, 2014
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Arthritis
Gout
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014