The Remote Monitoring of Gout Study

Официальное название

The ReMonit Gout Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 th
• Другое 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.

Первичные конечные точки

• Proportion of participants with serum urate level below the treatment target [Срок оценки: At 12 months after enrolment.]

Вторичные конечные точки (4)

• Proportion of participants with serum urate level below the treatment target at 24 months [Срок оценки: At 24 months after enrolment.]
• Mean serum urate level [Срок оценки: At 12 and 24 months after enrolment.]
• Time to treatment target is reached [Срок оценки: 1-24 months after enrolment.]
• Participant satisfaction with the follow-up care [Срок оценки: At 12 months after enrolment.]

Критерии участия

Критерии включения

• ≥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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Норвегия · 1 центр

• Diakonhjemmet Hospital — Oslo

Идентификаторы

NCT: NCT06822933 · 861240 · 24/04766

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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