NCT05031767已完成不适用
Remote Monitoring of Axial Spondyloarthritis in Specialist Healthcare Services
Diakonhjemmet Hospital2 个研究点 分布在 1 个国家目标入组 243 人开始时间: 2021年9月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 243
- 试验地点
- 2
- 主要终点
- Low disease activity at follow-up
研究概览
简要总结
The ReMonit study is a 18-months, non-inferiority randomized, controlled trial with three parallel arms to determine if two, new follow-up strategies for patients with axial spondyloarthritis (axSpA) are non-inferior in maintaining stable, low disease activity over time compared to the conventional follow-up regimen with regular hospital visits.
详细描述
The trial will include Norwegian adult males and females with axial spondyloarthritis.
240 participants will be randomized 1:1:1 to either:
- Control group: a. Usual care, i.e. conventional follow-up strategy with blood tests, patient-reported outcomes (PROs), and pre-scheduled visits at the hospital every 6th month
- Remote monitoring: hospital health professionals (HPs) perform remote monitoring of frequent PROs, blood test results, and physical activity data available on a digital platform
- Patient-initiated care: no pre-scheduled visits or remote monitoring
The study has 18 months follow-up. We will use a 15% non-inferiority margin.
The study will also include qualitative research including semi-structured interviews and observations of patients in the two intervention groups and health professionals involved in the study. The interviews will explore experiences with remote monitoring and video consultations.
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
- None
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
- •Male or non-pregnant, non-nursing female >18 years of age at screening
- •Patients with a diagnosis of axSpA who fulfil the diagnostic Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA
- •Stable medical treatment with TNFi the last 6 months
- •Low disease activity (ASDAS<2.1) at inclusion
- •Capable of understanding the Norwegian language and of signing an informed consent form
排除标准
- •Medical conditions:
- •Major co-morbidities, such as severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class III or IV), severe respiratory diseases, and/or cirrhosis.
- •Indications of active tuberculosis (TB)
- •Diagnostic assessments:
- •Abnormal renal function, defined as serum creatinine >142 µmol/L in female and >168 µmol/L in male, or glomerular filtration rate (GFR) <40 mL/min/1.73 m2
- •Abnormal liver function (defined as Alanine Transaminase (ALT) >3x upper normal limit), active or recent hepatitis
- •Leukopenia and/or thrombocytopenia
- •Pregnancy and/or breastfeeding (current at screening or planned within the duration of the study)
- •Severe psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
结局指标
主要结局
Low disease activity at follow-up
时间窗: 18 months
The proportion of patients with low disease activity (defined as ASDAS \<2.1) at the 18-months follow-up
次要结局
- Patient-reported flare(3, 6, 9, 12, 15 and 18 months)
- Ankylosing Spondylitis Disease Activity Score (ASDAS)(Every month, maximum 18 months)
- Patient global assessment of disease activity(3, 6, 9, 12, 15 and 18 months)
- Daily steps(Through study completion, maximum 18 months)
- Bath Ankylosing Spondylitis Functional Index (BASFI)(Baseline, 6, 12 and 18 months)
- Patient-reported global change in activity impairment(6, 12 and 18 months)
- Adverse events(Through study completion, maximum 18 months)
- Patient-reported global change in disease activity(6, 12 and 18 months)
- Tender joint count(Baseline, through study completion, and 18 months)
- The need to take time off work for hospital visits or video consultations(Baseline)
- Costs related to hospital visits(Baseline)
- C-Reactive Protein (CRP)(Every month, maximum 18 months)
- Activity Impairment(Baseline, 6, 12 and 18 months)
- Pain (general)(Baseline, 6, 12 and 18 months)
- Joint pain(Baseline, 6, 12 and 18 months)
- Sleep impairment(Baseline, 6, 12 and 18 months)
- Patient satisfaction with care(Baseline, 6, 12 and 18 months)
- Swollen joint count(Baseline, through study completion, and 18 months)
- Mean pulse level(Through study completion, maximum 18 months)
- Euro Quality of Life 5 Dimensions 5 Levels (EQ5D-5L)(Baseline, 6, 12 and 18 months)
- Concomitant medication(Baseline, 6, 12 and 18 months)
- Heel enthesitis(Baseline, through study completion, and 18 months)
- Health care utilization(Baseline, 6, 12 and 18 months)
- Extra visits, telephone and video consultations(Through study completion, maximum 18 months)
- eHealth literacy(Baseline)
- Body signs and symptoms(18 months)
- Withdrawals/Early discontinuation(Through study completion, maximum 18 months)
- Patient-reported self-efficacy for using different digital devices, secure login and digital health services measured on a Likert scale(Baseline)
- Preferred follow-up strategy(18 months)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Every month, maximum 18 months)
- Patient satisfaction with remote monitoring or patient-initiated care(18 months)
研究者
Nina Osteras
Principal investigator
Diakonhjemmet Hospital
研究点 (2)
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