Arthritis Research UK Gout Treatment Trial - Phase 2

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014