Gout Initiating Urate-loweringUrate-lowering TherapyReMonit GoutNCT06822933
The Remote Monitoring of Gout Study
A study testing Urika and Nurse-led follow-up with telephone consultations. in people with Gout Initiating Urate-loweringUrate-lowering Therapy, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout Initiating Urate-loweringUrate-lowering Therapy
- What is being tested?
- Urika and Nurse-led follow-up with telephone consultations.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jun 2025to Mar 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age at screening
- Patients with a clinical diagnosis of gout
- Patients who fulfil the ACR/EULAR classification criteria
- Serum urate level >360 µmol/L at inclusion
- At least 1 gout flare in the past 12 months
- Having a smartphone/tablet
Who cannot join
- Pregnant or breastfeeding
- Contraindication for urate lowering therapy
- Comedication azatioprin or 6-mercaptopurin
- Unstable medical conditions (e.g., uncontrollable hypertension, impaired liver function); known stage 3b or higher chronic kidney disease (estimated glomerular filtration (eGFR) rate/creatinine clearance <45 mL/min); severe infection or gastrointestinal bleed
- Major co-morbidities (e.g., malignancies, severe cardiovascular disease, severe diabetes mellitus, severe respiratory diseases)
- Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The ReMonit Gout Study
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.
Read the detailed description
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.
- Being tested
- Urika, Nurse-led follow-up with telephone consultations.
- Keywords
- gout, randomised controlled trial, remote monitoring, eHealth, Urate-lowering Theraphy
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrikaDevice
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 with telephone consultations.Other
Nurse-led follow-up in specialist healthcare with monthly blood tests and telephone consultations until the treatment target is reached.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | State-of-the-art nurse-led treat-to-target follow-up strategy. Receives: Other: Nurse-led follow-up with telephone consultations. |
| Digital self-management | Experimental | 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. Receives: Device: Urika |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 months after enrolment.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12 months after enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Jun 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gout Initiating Urate-loweringUrate-lowering TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Sor-Ost, The Dam Foundation
- Responsible party
- Principal investigator, Nina Osteras, Diakonhjemmet Hospital
- Investigators
- Nina Østerås, Prof., Principal investigator, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822933
- Sponsor's protocol ID
- 861240
- Other IDs
- 24/04766
- Acronym
- ReMonit Gout
- Status last verified
- Sep 2026
- First submitted
- 7 Feb 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only de-identified IPD used in the results publications from the trial can be made available.