Clinical trial NCT06822933: The Remote Monitoring of Gout Study
Official title: The ReMonit Gout Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Gout Initiating Urate-loweringUrate-lowering Therapy
Keywords: gout
randomised controlled trial
remote monitoring
eHealth
Urate-lowering Theraphy
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: Helse Sor-Ost
name: The Dam Foundation
First posted: 2025-02-12
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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 outcomes:
measure: Proportion of participants with serum urate level below the treatment target
timeFrame: At 12 months after enrolment.
Secondary outcomes:
measure: Proportion of participants with serum urate level below the treatment target at 24 months
timeFrame: At 24 months after enrolment.
measure: Mean serum urate level
timeFrame: At 12 and 24 months after enrolment.
measure: Time to treatment target is reached
timeFrame: 1-24 months after enrolment.
measure: Participant satisfaction with the follow-up care
timeFrame: At 12 months after enrolment.
Other outcomes:
measure: Number of acute gout flares
timeFrame: From enrolment to end of study at 24 months.
measure: Side-effects of urate lowering therapy
timeFrame: From enrolment to 12 months.
measure: Adverse events
timeFrame: From enrolment to 12 months.
measure: Adherence to serum urate lowering therapy
timeFrame: From enrolment to end of study at 24 months.
measure: Medication adherence
timeFrame: At 12 and 24 months.
measure: Knowledge of gout and recommended treatment
timeFrame: At Baseline, 12, and 24 months after enrolment.
measure: Beliefs about Medicines
timeFrame: At Baseline, 12, and 24 months.
measure: Health related quality of life
timeFrame: At Baseline, 12, and 24 months after enrolment.
measure: Overall health
timeFrame: At Baseline, 12, and 24 months after enrolment.
measure: Pain due to gout
timeFrame: At Baseline, 12, and 24 months.
measure: Patient global assessment of disease activity
timeFrame: At Baseline, 12, and 24 months.
measure: Activity Impairment
timeFrame: At Baseline, 12, and 24 months.
measure: Estimated costs
timeFrame: From enrolment to end of study at 24 months.
measure: System usability
timeFrame: Experimental arm (digital self-management): At 12 months.
measure: Satisfaction with the Urika app
timeFrame: Experimental arm (digital self-management): At 12 months.
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
state: Please Select
Study officials:
affiliation: Diakonhjemmet Hospital
name: Nina Østerås, Prof.
role: PRINCIPAL_INVESTIGATOR
References: