The ReMonit Gout Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Proportion of participants with serum urate level below the treatment target
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistical analyses will be conducted in line with the statistical analysis plan (SAP) by a biostatistician blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •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
研究组 & 干预措施
Usual care
State-of-the-art nurse-led treat-to-target follow-up strategy.
干预措施: Nurse-led follow-up with telephone consultations. (Other)
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.
干预措施: Urika (Device)
结局指标
主要结局
Proportion of participants with serum urate level below the treatment target
时间窗: At 12 months after enrolment.
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.
次要结局
- 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.)
研究者
Nina Osteras
Professor
Diakonhjemmet Hospital