GoutGout-SMARTNCT03274063
Gout Self-Monitoring Aiming to Reach Target
A study testing Supported self-management in people with Gout, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
This study evaluates whether a supported self-management approach to gout is able to achieve target levels of serum urate, and better control of gout flares. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout
- What is being tested?
- Supported self-management
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Apr 2019to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of gout (as per American College of Rheumatology criteria)
- Physician recommendation that escalation of urate lowering therapy with allopurinol or febuxostat is appropriate.
- Serum urate >0.36mm/L.
- Patient has a mobile phone and is able to install GoutSMART (Gout Self-monitoring Aiming to Reach Target urate) application.
Who cannot join
- Subject is unable to provide consent
- Severe renal failure (eGFR <30) or established liver disease
- Previous adverse reaction to allopurinol or febuxostat
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gout Self-Monitoring Aiming to Reach Target Serum Urate (Gout-SMART): Feasibility Study of Supported Self-management of Gout in Secondary Care Patients Requiring Escalation of Urate Lowering Therapy
This study evaluates whether a supported self-management approach to gout is able to achieve target levels of serum urate, and better control of gout flares.
Read the detailed description
Gout is the most common cause of inflammatory arthritis with recurrent gout flares a cause of reduced quality of life, work absence and disability. Effective treatments are widely available and yet many patients never achieve control of their disease. Resolution of gout attacks requires sustained lowering of the levels of serum urate, which in practise is seldom achieved. A supported self-management approach to gout has been developed which incorporates self-testing of urate levels and a smartphone application that will prompt participants to self-test and allow clinical researchers to titrate urate lowering therapies.
The feasibility of this approach will be evaluated in patients with gout referred to secondary care. Participants will be randomised 2:1 to the intervention or a control group. The intervention group will be offered supported self-management incorporating self-testing of serum urate. The control group will receive usual care from their primary care physician. The primary outcome will be the proportion of patients achieving levels of serum urate at or below 0.3mmol/l by 6 months. Participants will be followed up for a total of 12 months to assess the broader health and economic impact of the intervention.
- Conditions
- Gout
- Being tested
- Supported self-management, Usual care
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supported self-managementOther
Participants will be supplied with urate self-testing kits. Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data .
Usual careOther
Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
| Study group | Role | What they receive |
|---|---|---|
| Supported self-management | Active comparator | Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing Receives: Other: Supported self-management |
| Usual care | Sham comparator | Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Target Urate Levels (24 Weeks)
Percentage of participants achieving serum urate level at, or below, 0.3mmol/l
Measured: 24 weeks
Secondary outcomes (7)
Proportion of Participants Achieving Target Urate Levels (52 Weeks)
Proportion of participants achieving serum urate level at, or below, 0.3mmol/l
Measured: 52 weeks
Flare Frequency
Number of self-reported gout flares (months 7 to 12)
Measured: 52 weeks
Presence of Tophi
Percentage of participants with tophi at 52 weeks
Measured: 52 weeks
EQ-5D-5L Quality of Life Score
EQ-5D-5L (EuroqQol-5 level-5 dimension) self-reported quality of life score. Maximum score of 100 represents best possible health, minimum score of 0 represents worst possible health.
Measured: 52 weeks
Work Absences
Number of days lost at work due to gout flare
Measured: 52 weeks
Healthcare Utilisation
Number of scheduled and unscheduled medical appointments
Measured: 52 weeks
Self-reported Medication Compliance (24 Weeks)
Number of doses of medication omitted in preceding 2 weeks by self-report at 24 weeks.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start5 Apr 2019
- Primary completion19 Mar 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 EdinburghThe 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
- Model description
- Participants will be randomised in a ratio of 2:1 to either supported self management or usual care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Riches, University of Edinburgh
- Investigators
- Philip L Riches, FRCP PhD, Principal investigator, University of Edinburgh/NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274063
- Sponsor's protocol ID
- GoutSMART_NHSL_2YCR
- Acronym
- Gout-SMART
- Status last verified
- May 2024
- First submitted
- 30 Aug 2017
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available on request.
Publications
Riches PL, Alexander D, Hauser B, Kuske B, Krause A. Evaluation of supported self-management in gout (GoutSMART): a randomised controlled feasibility trial. Lancet Rheumatol. 2022 May;4(5):e320-e328. doi: 10.1016/S2665-9913(22)00062-5. Epub 2022 Mar 24.
PubMed 38294032
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gout Self-Monitoring Aiming to Reach Target Serum Urate (Gout-SMART): Feasibility Study of Supported Self-management of Gout in Secondary Care Patients Requiring Escalation of Urate Lowering Therapy
- ClinicalTrials.gov ID
- NCT03274063
- Acronym / sponsor ID
- Gout-SMART / GoutSMART_NHSL_2YCR
- Conditions
- Gout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Posted 21 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates whether a supported self-management approach to gout is able to achieve target levels of serum urate, and better control of gout flares.
Detailed description
Gout is the most common cause of inflammatory arthritis with recurrent gout flares a cause of reduced quality of life, work absence and disability. Effective treatments are widely available and yet many patients never achieve control of their disease. Resolution of gout attacks requires sustained lowering of the levels of serum urate, which in practise is seldom achieved. A supported self-management approach to gout has been developed which incorporates self-testing of urate levels and a smartphone application that will prompt participants to self-test and allow clinical researchers to titrate urate lowering therapies.
The feasibility of this approach will be evaluated in patients with gout referred to secondary care. Participants will be randomised 2:1 to the intervention or a control group. The intervention group will be offered supported self-management incorporating self-testing of serum urate. The control group will receive usual care from their primary care physician. The primary outcome will be the proportion of patients achieving levels of serum urate at or below 0.3mmol/l by 6 months. Participants will be followed up for a total of 12 months to assess the broader health and economic impact of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomised in a ratio of 2:1 to either supported self management or usual care.
| Arm | Type | Receives |
|---|---|---|
| Supported self-management | Active comparator | Other: Supported self-managementEscalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing |
| Usual care | Sham comparator | Other: Usual careEscalation of urate lowering therapy will remain the responsibility of the participants primary care physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of gout (as per American College of Rheumatology criteria)
- Physician recommendation that escalation of urate lowering therapy with allopurinol or febuxostat is appropriate.
- Serum urate >0.36mm/L.
- Patient has a mobile phone and is able to install GoutSMART (Gout Self-monitoring Aiming to Reach Target urate) application.
Key exclusion criteria (3 listed)
- Subject is unable to provide consent
- Severe renal failure (eGFR <30) or established liver disease
- Previous adverse reaction to allopurinol or febuxostat
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 |
|---|---|---|
| Supported self-managementParticipants will be supplied with urate self-testing kits. Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data . | Other | Supported self-management |
| Usual careParticipants will have a mobile phone application installed which will allow the research team to collect quality of life data. | Other | Usual care |
Primary outcome
Percentage of Participants Achieving Target Urate Levels (24 Weeks)
Time frame: 24 weeks
Percentage of participants achieving serum urate level at, or below, 0.3mmol/l
7 secondary outcomes
Proportion of Participants Achieving Target Urate Levels (52 Weeks)
Time frame: 52 weeks
Flare Frequency
Time frame: 52 weeks
Presence of Tophi
Time frame: 52 weeks
EQ-5D-5L Quality of Life Score
Time frame: 52 weeks
Work Absences
Time frame: 52 weeks
Healthcare Utilisation
Time frame: 52 weeks
Self-reported Medication Compliance (24 Weeks)
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38294032Riches PL, Alexander D, Hauser B, Kuske B, Krause A. Evaluation of supported self-management in gout (GoutSMART): a randomised controlled feasibility trial. Lancet Rheumatol. 2022 May;4(5):e320-e328. doi: 10.1016/S2665-9913(22)00062-5. Epub 2022 Mar 24.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available on request.
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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.
Philip L Riches, FRCP PhD principal investigator
University of Edinburgh/NHS Lothian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supported self-management in people with Gout, run by University of Edinburgh 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 4 inclusion and 3 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 21 May 2024. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 21 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Achieving Target Urate Levels (24 Weeks) (time frame: 24 weeks). 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 NCT03274063, which also lists 1 linked publication.
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 21 May 2024.