The Remote Monitoring of Gout Study

NCT06822933 | Enrolling By Invitation

• 2 other identifiers: 86124024/04766
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

gout; randomised controlled trial; remote monitoring; eHealth; Urate-lowering Theraphy

Outcome Measures

Primary Outcomes (1)

• 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.

  At 12 months after enrolment.

Secondary Outcomes (4)

• Proportion of participants with serum urate level below the treatment target at 24 months

  At 24 months after enrolment.

• Mean serum urate level

  At 12 and 24 months after enrolment.

• Time to treatment target is reached

  1-24 months after enrolment.

• Participant satisfaction with the follow-up care

  At 12 months after enrolment.

Other Outcomes (15)

• Number of acute gout flares

  From enrolment to end of study at 24 months.

• Side-effects of urate lowering therapy

  From enrolment to 12 months.

• Adverse events

  From enrolment to 12 months.

Study Arms (2)

Usual care

ACTIVE COMPARATOR

State-of-the-art nurse-led treat-to-target follow-up strategy.

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.

Device: Urika

Interventions

Urika DEVICE

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.

Digital self-management

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.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age at screening
• Patients with a clinical diagnosis of gout
• Patients who fulfil the ACR/EULAR classification criteria
• At least 1 gout flare in the past 12 months
• Having a smartphone/tablet

You may not qualify if:

• 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

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead
• Helse Sor-Ost: collaborator
• The Dam Foundation: collaborator

Study Sites (1)

Diakonhjemmet Hospital

Oslo, Please Select, 0319, Norway

Location

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nina Østerås, Prof.

  Diakonhjemmet Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistical analyses will be conducted in line with the statistical analysis plan (SAP) by a biostatistician blinded to group allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 12, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

NO (1)