N/A
N=60
Gout Self-Monitoring Aiming to Reach Target
Gout
Bottom Line
View on ClinicalTrials.gov: NCT03274063 ↗Enrolled (actual)
60
Serious AEs
11.7%
Results posted
May 2024
Primary outcome: Primary: Percentage of Participants Achieving Target Urate Levels (24 Weeks) — 29; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Supported self-management (Other); Usual care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Edinburgh
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Target Urate Levels (24 Weeks) |
29; 3 | — |
| SECONDARY Proportion of Participants Achieving Target Urate Levels (52 Weeks) |
32; 9 | — |
| SECONDARY Flare Frequency |
0.81; 2.06 | — |
| SECONDARY Presence of Tophi |
8; 5 | — |
| SECONDARY EQ-5D-5L Quality of Life Score |
83.4; 79.1 | — |
| SECONDARY Work Absences |
0.24; 0.11 | — |
| SECONDARY Healthcare Utilisation |
0.083; 0.67 | — |
| SECONDARY Self-reported Medication Compliance (24 Weeks) |
0.57; 1.32 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03274063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.