The Remote Monitoring of Gout Study

NCT06822933 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2025-06-10

No results posted yet for this 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.

Conditions

  • Gout Initiating Urate-loweringUrate-lowering Therapy

Interventions

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.

OTHER

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.

Sponsors & Collaborators

  • Helse Sor-Ost

    collaborator OTHER_GOV
  • The Dam Foundation

    collaborator OTHER
  • Diakonhjemmet Hospital

    lead OTHER

Principal Investigators

  • Nina Østerås, Prof. · Diakonhjemmet Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2028-03-31
Completion
2029-03-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06822933 on ClinicalTrials.gov