The Remote Monitoring of Gout Study (ReMonit Gout)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Gout Initiating Urate-loweringUrate-lowering Therapy
• Intervention / Treatment: Other: Nurse-led follow-up with telephone consultations.; Device: Urika

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.

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Please Select
    • Oslo, Please Select, Norway, 0319
      • Diakonhjemmet Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care; State-of-the-art nurse-led treat-to-target follow-up strategy.	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.
Experimental: Digital self-management; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	At 12 months after enrolment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of acute gout flares	Number of participant-reported acute gout flares fulfilling the GAFFO criteria, i.e., fulfilment of at least 3 of 4 patient-reported criteria: patient-defined gout attack, pain at rest score of >3 on a 0-10 numeric rating scale, presence of at least one swollen joint, and presence of at least one warm joint. Self-reported every 3rd month in a digital questionnaire. Analyses at 12 and 24 months.	From enrolment to end of study at 24 months.
Adherence to serum urate lowering therapy	Participant-reported adherence to serum urate lowering therapy in the last week and the last month. The participants self-report the number of days they have missed taking their urate lowering medication in the last week and in the last month. Collected every 3rd month from enrolment to end of study at 24 months. Analyses at 12 and 24 months.	From enrolment to end of study at 24 months.
Estimated costs	Estimated costs related to the interventions, healthcare utilisation and other associated costs, time off work and sickness absence. We will use participant-reported data on time off work and travel expenses, data from the intervention providers on time spent providing the interventions, and data from national registries on: healthcare consultations in primary and specialist health care, medication prescriptions, sickness absence, work assessment allowance, and disability benefits. Analyses at 12 and 24 months.	From enrolment to end of study at 24 months.
System usability	System Usability Scale (SUS). Ten items scored on a 5-point Likert scale (Strongly disagree - Strongly agree, sum score 0-40, which is converted into 0-100, 100= best score). A SUS score above a 68 would be considered above average and anything below 68 is below average.	Experimental arm (digital self-management): At 12 months.
Satisfaction with the Urika app	Satisfaction with the Urika app, includes one item rated on a 0-10 numeric rating scale ranging from "Very satisfied" to "Very dissatisfied".	Experimental arm (digital self-management): At 12 months.
Knowledge of gout and recommended treatment	The Gout Knowledge Questionnaire, which includes 10 multiple choice questions assessing patients' knowledge on pathogenesis, treatment of acute gout attacks, and management of chronic gout. Score range: 0-10 (number of correct answers), score 10 is the best outcome	At Baseline, 12, and 24 months after enrolment.
Beliefs about Medicines	The Beliefs about Medicines Questionnaire (BMQ) - Specific. Comprises two 5-item subscales assessing beliefs about the necessity of prescribed medication (Specific-Necessity) and concerns about prescribed medication based on beliefs about the danger of dependence and long-term toxicity and the disruptive effects of medication (Specific-Concerns). Likert scale scored 1-5 per item. Scores for Specific-Necessity and for Specific-Concerns are calculated separately, and higher scores indicate stronger beliefs in the concepts of the sub-scale.	At Baseline, 12, and 24 months.
Health related quality of life	Health related quality of life measured by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L). The EQ-5D-5L is a generic and preference-weighted measure of health-related quality-of-life based on 5 dimensions: mobility, self-care, activities of daily life, pain, and anxiety/depression. For each dimension, the participant assesses 5 possible levels of problems (from no to severe, which is scored from 1 to 5, higher scores indicate worse outcome). EQ-5D index values will be calculated.	At Baseline, 12, and 24 months after enrolment.
Overall health	Participant-reported general health is part of the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) instrument, scored on a visual analog scale (VAS) 0-100, higher score indicates better general health.	At Baseline, 12, and 24 months after enrolment.
Pain due to gout	Pain in the past week due to gout self-reported on a 0-10 numeric rating scale. Higher scores indicate worse outcome.	At Baseline, 12, and 24 months.
Patient global assessment of disease activity	Patient global assessment of disease activity self-reported on a 0-10 numeric rating scale. Higher scores indicate worse outcome.	At Baseline, 12, and 24 months.
Activity Impairment	Work Productivity and Activity Impairment (WPAI), item no.6. Self-reported activity impairment, reported on a 0-10 numeric rating scale. Higher scores indicate worse outcome.	At Baseline, 12, and 24 months.
Medication adherence	Participant-reported adherence to medication using the Medication adherence report scale (MARS-5), which included 5 items with a 5-point Likert scale (1=always, 2=often, 3=sometimes, 4=rarely, 5=never) and score range 5-25. Score 25 is best outcome, and a score of 23-25 is considered adherent.	At 12 and 24 months.
Side-effects of urate lowering therapy	Number and type of participant-reported side-effects of urate lowering therapy. Self-reported every 3rd month in a digital questionnaire, during telephone consultations, or reported in the chat in the self-management app. Analyses at 12 months.	From enrolment to 12 months.
Adverse events	Number and type of registered adverse events including serious adverse events, adverse device effects, and serious adverse device effects. Self-reported every 3rd month in a digital questionnaire, in telephone consultations, or reported in the chat in the self-management app. Analyses at 12 months.	From enrolment to 12 months.

Collaborators and Investigators

• Sponsor: Diakonhjemmet Hospital
• Collaborators: The Dam Foundation; Helse Sor-Ost
• Investigators: Principal Investigator: Nina Østerås, Prof., Diakonhjemmet Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: eHealth; randomised controlled trial; gout; remote monitoring; Urate-lowering Theraphy
• Additional Relevant MeSH Terms: Crystal Arthropathies; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Gout
• Other Study ID Numbers: 861240; 24/04766 (Other Identifier: Diakonhjemmet Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only de-identified IPD used in the results publications from the trial can be made available.
• IPD Sharing Time Frame: The IPD will be availabel from 2039
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No