Arthritis Research UK Gout Treatment Trial - Phase 2
This study is currently recruiting participants.
Verified April 2013 by University of Nottingham
Sponsor:
University of Nottingham
Collaborator:
Arthritis Research UK
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01477346
First received: November 14, 2011
Last updated: April 4, 2013
Last verified: April 2013
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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: | April 4, 2013 |
| 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 May 16, 2013