Gout
Conditions
Brief 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.
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.
Interventions
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 .
OTHERUsual care
Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
Sponsors
University of Edinburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Laboratory staff measuring biochemical traits will be blind to treatment allocation.
Intervention model description
Participants will be randomised in a ratio of 2:1 to either supported self management or usual care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Subject is unable to provide consent * Severe renal failure (eGFR \<30) or established liver disease * Previous adverse reaction to allopurinol or febuxostat
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Target Urate Levels (24 Weeks) | 24 weeks | Percentage of participants achieving serum urate level at, or below, 0.3mmol/l |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving Target Urate Levels (52 Weeks) | 52 weeks | Proportion of participants achieving serum urate level at, or below, 0.3mmol/l |
| Flare Frequency | 52 weeks | Number of self-reported gout flares (months 7 to 12) |
| Presence of Tophi | 52 weeks | Percentage of participants with tophi at 52 weeks |
| EQ-5D-5L Quality of Life Score | 52 weeks | 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. |
| Work Absences | 52 weeks | Number of days lost at work due to gout flare |
| Healthcare Utilisation | 52 weeks | Number of scheduled and unscheduled medical appointments |
| Self-reported Medication Compliance (24 Weeks) | 24 weeks | Number of doses of medication omitted in preceding 2 weeks by self-report at 24 weeks. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 . | 40 |
| 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. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Supported Self-management | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 53.0 years STANDARD_DEVIATION 15 | 52.6 years STANDARD_DEVIATION 14.1 | 52.8 years STANDARD_DEVIATION 14.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 38 Participants | 20 Participants | 58 Participants |
| Region of Enrollment United Kingdom | 40 participants | 20 participants | 60 participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 37 Participants | 19 Participants | 56 Participants |
| Tophi | 10 Participants | 6 Participants | 16 Participants |
| Urate | 0.47 mmol/L STANDARD_DEVIATION 0.07 | 0.51 mmol/L STANDARD_DEVIATION 0.1 | 0.48 mmol/L STANDARD_DEVIATION 0.09 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 40 | 0 / 20 |
| other Total, other adverse events | 7 / 40 | 3 / 20 |
| serious Total, serious adverse events | 3 / 40 | 4 / 20 |
Outcome results
Primary
Percentage of Participants Achieving Target Urate Levels (24 Weeks)
Percentage of participants achieving serum urate level at, or below, 0.3mmol/l
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supported Self-management | Percentage of Participants Achieving Target Urate Levels (24 Weeks) | 29 Participants |
| Usual Care | Percentage of Participants Achieving Target Urate Levels (24 Weeks) | 3 Participants |
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.
Time frame: 52 weeks
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supported Self-management | EQ-5D-5L Quality of Life Score | 83.4 units on a scale | Standard Deviation 11.1 |
| Usual Care | EQ-5D-5L Quality of Life Score | 79.1 units on a scale | Standard Deviation 12 |
Secondary
Flare Frequency
Number of self-reported gout flares (months 7 to 12)
Time frame: 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supported Self-management | Flare Frequency | 0.81 number of self-reported gout flares | Standard Deviation 1.06 |
| Usual Care | Flare Frequency | 2.06 number of self-reported gout flares | Standard Deviation 2.6 |
Secondary
Healthcare Utilisation
Number of scheduled and unscheduled medical appointments
Time frame: 52 weeks
Population: Measure available only in participants completing study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supported Self-management | Healthcare Utilisation | 0.083 Number of medical appointments | Standard Deviation 0.37 |
| Usual Care | Healthcare Utilisation | 0.67 Number of medical appointments | Standard Deviation 1.08 |
Secondary
Presence of Tophi
Percentage of participants with tophi at 52 weeks
Time frame: 52 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supported Self-management | Presence of Tophi | 8 Participants |
| Usual Care | Presence of Tophi | 5 Participants |
Secondary
Proportion of Participants Achieving Target Urate Levels (52 Weeks)
Proportion of participants achieving serum urate level at, or below, 0.3mmol/l
Time frame: 52 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supported Self-management | Proportion of Participants Achieving Target Urate Levels (52 Weeks) | 32 Participants |
| Usual Care | Proportion of Participants Achieving Target Urate Levels (52 Weeks) | 9 Participants |
Secondary
Self-reported Medication Compliance (24 Weeks)
Number of doses of medication omitted in preceding 2 weeks by self-report at 24 weeks.
Time frame: 24 weeks
Population: Measure available only in participants completing study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supported Self-management | Self-reported Medication Compliance (24 Weeks) | 0.57 Number of doses missed | Standard Deviation 1.63 |
| Usual Care | Self-reported Medication Compliance (24 Weeks) | 1.32 Number of doses missed | Standard Deviation 2.63 |
Secondary
Work Absences
Number of days lost at work due to gout flare
Time frame: 52 weeks
Population: Measure available only in participants completing study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supported Self-management | Work Absences | 0.24 number of work days lost | Standard Deviation 1.35 |
| Usual Care | Work Absences | 0.11 number of work days lost | Standard Deviation 0.47 |