The Remote Monitoring of Gout Study

NCT06822933 · tracked via the Priya Life Science Norway tracker

Sponsor

Diakonhjemmet Hospital

Phase

Not applicable

Started

2025-06-01

Last updated

2025-06-10

Condition(s) studied

Gout Initiating Urate-loweringUrate-lowering Therapy

Investigational drug(s) / intervention(s)

UrikaNurse-led follow-up with telephone consultations.

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 with telephone consultations.: Nurse-led follow-up in specialist healthcare with monthly blood tests and telephone consultations until the treatment target is reached.

Study 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. 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * ≥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 Exclusion Criteria: * 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

Primary outcome measure(s)

Proportion of participants with serum urate level below the treatment target — At 12 months after enrolment.
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.

Trial sites (1)

Facility	City	Region	Status
Diakonhjemmet Hospital	Oslo	Please Select

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06822933 on ClinicalTrials.gov ↗ ← All trials in Norway