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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supported self-management | Active Comparator | Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing |
|
| Usual care | Sham Comparator | Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supported self-management | Other | 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Target Urate Levels (24 Weeks) | Percentage of participants achieving serum urate level at, or below, 0.3mmol/l | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving Target Urate Levels (52 Weeks) | Proportion of participants achieving serum urate level at, or below, 0.3mmol/l | 52 weeks |
| Flare Frequency | Number of self-reported gout flares (months 7 to 12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip L Riches, FRCP PhD | University of Edinburgh/NHS Lothian | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38294032 | Derived | 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. |
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De-identified individual participant data for all primary and secondary outcome measures will be made available on request.
Data will be available within 6 months of study completion.
Data access requests will be reviewed by the principal investigator. Requestors will be required to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Supported Self-management | Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing Supported self-management: 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 . |
| FG001 | Usual Care | Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician. Usual care: Participants will have a mobile phone application installed which will allow the research team to collect quality of life data. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Supported Self-management | Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing Supported self-management: 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 . |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Target Urate Levels (24 Weeks) | Percentage of participants achieving serum urate level at, or below, 0.3mmol/l | Posted | Count of Participants | Participants | 24 weeks |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Supported Self-management | Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing Supported self-management: 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 . |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular accident | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdo pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Philip Riches | University of Edinburgh | 07944625313 | priches@staffmail.ed.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2021 | May 7, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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Participants will be randomised in a ratio of 2:1 to either supported self management or usual care.
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Laboratory staff measuring biochemical traits will be blind to treatment allocation.
|
| Usual care | Other | Participants will have a mobile phone application installed which will allow the research team to collect quality of life data. |
|
| 52 weeks |
| Presence of Tophi | Percentage of participants with tophi at 52 weeks | 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. | 52 weeks |
| Work Absences | Number of days lost at work due to gout flare | 52 weeks |
| Healthcare Utilisation | Number of scheduled and unscheduled medical appointments | 52 weeks |
| Self-reported Medication Compliance (24 Weeks) | Number of doses of medication omitted in preceding 2 weeks by self-report at 24 weeks. | 24 weeks |
| BG001 | Usual Care | Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician. Usual care: Participants will have a mobile phone application installed which will allow the research team to collect quality of life data. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Tophi | Percentage of participants with self-reported tophi | Count of Participants | Participants |
|
| Urate | Mean | Standard Deviation | mmol/L |
|
Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.
Usual care: Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
|
|
| Secondary | Proportion of Participants Achieving Target Urate Levels (52 Weeks) | Proportion of participants achieving serum urate level at, or below, 0.3mmol/l | Posted | Count of Participants | Participants | 52 weeks |
|
|
|
| Secondary | Flare Frequency | Number of self-reported gout flares (months 7 to 12) | Posted | Mean | Standard Deviation | number of self-reported gout flares | 52 weeks |
|
|
|
| Secondary | Presence of Tophi | Percentage of participants with tophi at 52 weeks | Posted | Count of Participants | Participants | 52 weeks |
|
|
|
| Secondary | 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. | Recording of quality of life data was incomplete in this study and only available at close in the number of participants shown. This limitation is acknowledged in the published article of this trial | Posted | Mean | Standard Deviation | units on a scale | 52 weeks |
|
|
|
| Secondary | Work Absences | Number of days lost at work due to gout flare | Measure available only in participants completing study | Posted | Mean | Standard Deviation | number of work days lost | 52 weeks |
|
|
|
| Secondary | Healthcare Utilisation | Number of scheduled and unscheduled medical appointments | Measure available only in participants completing study | Posted | Mean | Standard Deviation | Number of medical appointments | 52 weeks |
|
|
|
| Secondary | Self-reported Medication Compliance (24 Weeks) | Number of doses of medication omitted in preceding 2 weeks by self-report at 24 weeks. | Measure available only in participants completing study | Posted | Mean | Standard Deviation | Number of doses missed | 24 weeks |
|
|
|
| 1 |
| 40 |
| 3 |
| 40 |
| 7 |
| 40 |
| EG001 | Usual Care | Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician. Usual care: Participants will have a mobile phone application installed which will allow the research team to collect quality of life data. | 0 | 20 | 4 | 20 | 3 | 20 |
| Hip replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bowel cancer | Gastrointestinal disorders | Systematic Assessment |
|
| skull fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |