An interventional study of Urika and Nurse-led follow-up with telephone consultations. in Gout Initiating Urate-loweringUrate-lowering Therapy, sponsored by Diakonhjemmet Hospital. Enrolling by invitation at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Diakonhjemmet Hospital · Not applicable, Interventional, and Health services research
The goal of this clinical trial is to: compare a new digital self-management treatment strategy to usual care, for patients with gout receiving urate lowering therapy in specialist healthcare. The digital self-management strategy consists of app-based remote follow-up with the 'Urica' app, and remote monitoring by a nurse. Usual care consists of state-of-the-art nurse-led treat-to-target follow-up, with regular telephone consultations. The main question the study aims to answer is:
Is the digital self-management strategy for patients with gout non-inferior compared to usual care in obtaining and maintaining a low serum urate level at 12 months.
The trial is a non-inferiority, parallel-group, pragmatic, randomised controlled trial, with 24 months follow-up.
A 15% non-inferiority margin will be used.
Patients with gout will be recruited from the outpatient clinic at Diakohjemmet Hospital, Oslo, Norway. 168 adults with a gout diagnosis and serum urate level >360 μmol/L will be recruited and then randomised 1:1 to either usual care or digital self-management.
All participants will have a face-to-face consultation with a nurse prior to entering the study. The nurse will inform about gout and gout management strategy, the medication start-up dose, and the serum urate level treatment-target (\<360 µmol/L, or \<300 µmol/L for participants with tophi). All participants will take a monthly blood-test and increase their urate lowering medication dose until they reach the serum urate level treatment-target.
Usual care: Participants receiving usual care will have monthly telephone consultations with a nurse, who will inform about the medication dose for the next month.
Digital self-management: Participants receiving the digital self-management strategy will get help to download the 'Urika' -app, and instructions in how to use the app. They will register the following information in the app: the serum urate treatment target, type of urate lowering medication, side effects from medication, medical adherene, and the serum urate level from the monthly blood test. An algorithm in the app will calculate the medication drug-dose escalation. The study nurse will monitor the participants' progress through a secure web-platform.
All participants will answer digital questionnaires and take blood tests at baseline, 12 and 24 month follow-ups and answer a short digital questionnaire every 3 months.
A process end economic evaluation will be conducted alongside the trial. The process evaluation will include data from interviews with participants and nurses providing the interventions, and back-end data from the 'Urica'-app.
345 studies on the registry are indexed under Gout; 49 are open to participants now.
This study's planned enrollment of 168 is above the median of 83 across 286 interventional studies indexed under Gout.
Browse Gout studies →Diakonhjemmet Hospital is the lead sponsor of 62 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
State-of-the-art nurse-led treat-to-target follow-up strategy.
Other: Nurse-led follow-up with telephone consultations.
Digital self-management strategy with patient self-management app, monthly blood tests, and remote monitoring by the study nurse until the treatment target is reached.
Device: Urika
Self-management application for patients with gout receiving urate lowering therapy. The 'Urika'-app includes films and written information about gout and gout management, reminders for blood-tests and medication, a visualisation of serum urate level over time, and an algorithm to calculate the medication drug-dose escalation. The app also includes a chat function and a secure web-platform for remote monitoring and communication between the participant and nurse. The study nurse will log into the web-platform on weekdays to check patient-reported side effects, adherence to medication, the current dose, and the need for a renewal of urate lowering therapy prescription.
Nurse-led follow-up in specialist healthcare with monthly blood tests and telephone consultations until the treatment target is reached.
Proportion of participants with serum urate level below the treatment target
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.
Time frame: At 12 months after enrolment.
Proportion of participants with serum urate level below the treatment target at 24 months
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.
Time frame: At 24 months after enrolment.
Mean serum urate level
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.
Time frame: At 12 and 24 months after enrolment.
Time to treatment target is reached
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.
Time frame: 1-24 months after enrolment.
Participant satisfaction with the follow-up care
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.
Time frame: At 12 months after enrolment.
Number of acute gout flares
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.
Time frame: From enrolment to end of study at 24 months.
Side-effects of urate lowering therapy
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.
Time frame: From enrolment to 12 months.
Adverse events
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.
Time frame: From enrolment to 12 months.
Adherence to serum urate lowering therapy
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.
Time frame: From enrolment to end of study at 24 months.
Medication adherence
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.
Time frame: At 12 and 24 months.
Knowledge of gout and recommended treatment
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
Time frame: At Baseline, 12, and 24 months after enrolment.
Beliefs about Medicines
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.
Time frame: At Baseline, 12, and 24 months.
Health related quality of life
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.
Time frame: At Baseline, 12, and 24 months after enrolment.
Overall health
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.
Time frame: At Baseline, 12, and 24 months after enrolment.
Pain due to gout
Pain in the past week due to gout self-reported on a 0-10 numeric rating scale. Higher scores indicate worse outcome.
Time frame: At Baseline, 12, and 24 months.
Patient global assessment of disease activity
Patient global assessment of disease activity self-reported on a 0-10 numeric rating scale. Higher scores indicate worse outcome.
Time frame: At Baseline, 12, and 24 months.
Activity Impairment
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.
Time frame: At Baseline, 12, and 24 months.
Estimated costs
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.
Time frame: From enrolment to end of study at 24 months.
System usability
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.
Time frame: Experimental arm (digital self-management): At 12 months.
Satisfaction with the Urika app
Satisfaction with the Urika app, includes one item rated on a 0-10 numeric rating scale ranging from "Very satisfied" to "Very dissatisfied".
Time frame: Experimental arm (digital self-management): At 12 months.
Plan to share: Yes — Only de-identified IPD used in the results publications from the trial can be made available.
Time frame: The IPD will be availabel from 2039
Access criteria: The data will only be made available to researchers upon reasonable request. Data will only be provided after submission of a project plan outlining the reason for the request and the planned analyses. The request will have to be approved by the ReMonit Gout project group.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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