GoutNCT01477346
Arthritis Research UK Gout Treatment Trial - Phase 2
A study testing Nurse intervention in people with Gout, run by University of Nottingham at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Gout
- What is being tested?
- Nurse intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 517 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2013to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of gout
- At least one acute attack of gout within previous 12 months
Who cannot join
- Inability to give informed consent and known terminal or mental illness
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Rheumatology, University of Nottingham
Nottingham, NG5 1PB
About this study
Official title: Arthritis Research UK Gout Treatment Trial. Phase 2: Two Year Randomised Controlled Trial of a Nurse Led Package of Care
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).
- Conditions
- Gout
- Being tested
- Nurse intervention, Standard care
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse interventionOther
Complex package of care involving patient information and advice concerning lifestyle modification and recommended drug therapy.
Standard careOther
Continuing standard General Practitioner led care.
| Study group | Role | What they receive |
|---|---|---|
| Nurse intervention | Other | Nurse led package of care based on current recommended best practice. Receives: Other: Nurse intervention |
| Standard care | Other | Continuing standard general practitioner led care Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in serum uric acid levels
Measured: 2 years
Secondary outcomes (2)
Reduction in number of self reported acute attacks during year 2
Measured: 2 years
Improved Quality of Life scores at study end
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startMar 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 517 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Research UK
- Responsible party
- Sponsor
- Investigators
- Michael Doherty, MA MD FRCP, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477346
- Sponsor's protocol ID
- 11115
- Status last verified
- Jan 2017
- First submitted
- 14 Nov 2011
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Stamp LK, Frampton C, Morillon MB, Taylor WJ, Dalbeth N, Singh JA, Doherty M, Zhang W, Richardson H, Sarmanova A, Christensen R. Association between serum urate and flares in people with gout and evidence for surrogate status: a secondary analysis of two randomised controlled trials. Lancet Rheumatol. 2022 Jan;4(1):e53-e60. doi: 10.1016/S2665-9913(21)00319-2. Epub 2021 Nov 5.
PubMed 38288731Doherty M, Jenkins W, Richardson H, Sarmanova A, Abhishek A, Ashton D, Barclay C, Doherty S, Duley L, Hatton R, Rees F, Stevenson M, Zhang W. Efficacy and cost-effectiveness of nurse-led care involving education and engagement of patients and a treat-to-target urate-lowering strategy versus usual care for gout: a randomised controlled trial. Lancet. 2018 Oct 20;392(10156):1403-1412. doi: 10.1016/S0140-6736(18)32158-5.
PubMed 30343856
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthritis Research UK Gout Treatment Trial. Phase 2: Two Year Randomised Controlled Trial of a Nurse Led Package of Care
- ClinicalTrials.gov ID
- NCT01477346
- Acronym / sponsor ID
- 11115
- Conditions
- Gout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Arthritis Research UK
- Study start
- Mar 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse intervention | Other | Other: Nurse interventionNurse led package of care based on current recommended best practice. |
| Standard care | Other | Other: Standard careContinuing standard general practitioner led care |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of gout
- At least one acute attack of gout within previous 12 months
Key exclusion criteria (1 listed)
- Inability to give informed consent and known terminal or mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse interventionComplex package of care involving patient information and advice concerning lifestyle modification and recommended drug therapy. | Other | Nurse intervention |
| Standard careContinuing standard General Practitioner led care. | Other | Standard care |
Primary outcome
Reduction in serum uric acid levels
Time frame: 2 years
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- Derived from this study: PubMed 38288731Stamp LK, Frampton C, Morillon MB, Taylor WJ, Dalbeth N, Singh JA, Doherty M, Zhang W, Richardson H, Sarmanova A, Christensen R. Association between serum urate and flares in people with gout and evidence for surrogate status: a secondary analysis of two randomised controlled trials. Lancet Rheumatol. 2022 Jan;4(1):e53-e60. doi: 10.1016/S2665-9913(21)00319-2. Epub 2021 Nov 5.
- Derived from this study: PubMed 30343856Doherty M, Jenkins W, Richardson H, Sarmanova A, Abhishek A, Ashton D, Barclay C, Doherty S, Duley L, Hatton R, Rees F, Stevenson M, Zhang W. Efficacy and cost-effectiveness of nurse-led care involving education and engagement of patients and a treat-to-target urate-lowering strategy versus usual care for gout: a randomised controlled trial. Lancet. 2018 Oct 20;392(10156):1403-1412. doi: 10.1016/S0140-6736(18)32158-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Doherty, MA MD FRCP principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse intervention in people with Gout, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in serum uric acid levels (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01477346, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2017.