The Remote Monitoring of Gout Study
NCT06822933 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168
Last updated 2025-06-10
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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