The Remote Monitoring of Gout Study

The proportion with low serum urate level (<360/300 μmol/L) at 12 months. Serum urate level is collected from blood test results taken at the 12-month follow-up.

The proportion with low serum urate level (<360/300 μmol/L) at 24 months. Serum urate level is collected from blood test results taken at 24-month follow-up.

The participants' mean serum urate level at 12 and 24 months. Serum urate level is collected from blood test results taken at 12 and 24 months follow-up.

The mean time from enrolment to treatment target (serum urate level <360/300 μmol/L) is reached. Serum urate level is collected from blood test results conducted every month until the treatment target is reached. Analyses at 12 and 24 months.

Participant satisfaction with the care, measured by one item from The Nordic Patient Experiences Questionnaire, with five point response options ranging from "Very satisfied" to "Very dissatisfied" at 12 months.

Number of participant-reported acute gout flares fulfilling the GAFFO criteria, i.e., fulfilment of at least 3 of 4 patient-reported criteria: patient-defined gout attack, pain at rest score of >3 on a 0-10 numeric rating scale, presence of at least one swollen joint, and presence of at least one warm joint. Self-reported every 3rd month in a digital questionnaire. Analyses at 12 and 24 months.

Number and type of participant-reported side-effects of urate lowering therapy. Self-reported every 3rd month in a digital questionnaire, during telephone consultations, or reported in the chat in the self-management app. Analyses at 12 months.

Number and type of registered adverse events including serious adverse events, adverse device effects, and serious adverse device effects. Self-reported every 3rd month in a digital questionnaire, in telephone consultations, or reported in the chat in the self-management app. Analyses at 12 months.

Participant-reported adherence to serum urate lowering therapy in the last week and the last month. The participants self-report the number of days they have missed taking their urate lowering medication in the last week and in the last month. Collected every 3rd month from enrolment to end of study at 24 months. Analyses at 12 and 24 months.

Participant-reported adherence to medication using the Medication adherence report scale (MARS-5), which included 5 items with a 5-point Likert scale (1=always, 2=often, 3=sometimes, 4=rarely, 5=never) and score range 5-25. Score 25 is best outcome, and a score of 23-25 is considered adherent.

The Gout Knowledge Questionnaire, which includes 10 multiple choice questions assessing patients' knowledge on pathogenesis, treatment of acute gout attacks, and management of chronic gout. Score range: 0-10 (number of correct answers), score 10 is the best outcome

The Beliefs about Medicines Questionnaire (BMQ) - Specific. Comprises two 5-item subscales assessing beliefs about the necessity of prescribed medication (Specific-Necessity) and concerns about prescribed medication based on beliefs about the danger of dependence and long-term toxicity and the disruptive effects of medication (Specific-Concerns). Likert scale scored 1-5 per item. Scores for Specific-Necessity and for Specific-Concerns are calculated separately, and higher scores indicate stronger beliefs in the concepts of the sub-scale.

Health related quality of life measured by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L). The EQ-5D-5L is a generic and preference-weighted measure of health-related quality-of-life based on 5 dimensions: mobility, self-care, activities of daily life, pain, and anxiety/depression. For each dimension, the participant assesses 5 possible levels of problems (from no to severe, which is scored from 1 to 5, higher scores indicate worse outcome). EQ-5D index values will be calculated.

Participant-reported general health is part of the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) instrument, scored on a visual analog scale (VAS) 0-100, higher score indicates better general health.

Pain in the past week due to gout self-reported on a 0-10 numeric rating scale. Higher scores indicate worse outcome.

Patient global assessment of disease activity self-reported on a 0-10 numeric rating scale. Higher scores indicate worse outcome.

Work Productivity and Activity Impairment (WPAI), item no.6. Self-reported activity impairment, reported on a 0-10 numeric rating scale. Higher scores indicate worse outcome.

Estimated costs related to the interventions, healthcare utilisation and other associated costs, time off work and sickness absence. We will use participant-reported data on time off work and travel expenses, data from the intervention providers on time spent providing the interventions, and data from national registries on: healthcare consultations in primary and specialist health care, medication prescriptions, sickness absence, work assessment allowance, and disability benefits. Analyses at 12 and 24 months.

System Usability Scale (SUS). Ten items scored on a 5-point Likert scale (Strongly disagree - Strongly agree, sum score 0-40, which is converted into 0-100, 100= best score). A SUS score above a 68 would be considered above average and anything below 68 is below average.

Satisfaction with the Urika app, includes one item rated on a 0-10 numeric rating scale ranging from "Very satisfied" to "Very dissatisfied".