Remote Monitoring of Axial Spondyloarthritis in Specialist Healthcare Services
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
- 1
- 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
研究组 & 干预措施
Usual care
Conventional current follow-up strategy
干预措施: Usual care (Other)
Remote monitoring
Remote monitoring by health professionals at the hospital
干预措施: Remote monitoring (Other)
Patient-initiated care
No pre-scheduled visits or remote monitoring.
干预措施: Patient-initiated care (Other)
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
Low disease activity at follow-up
时间窗: 6 months
The proportion of patients with low disease activity (defined as ASDAS \<2.1) at the 6-months follow-up
Low disease activity at follow-up
时间窗: 12 months
The proportion of patients with low disease activity (defined as ASDAS \<2.1) at the 12- months follow-up
次要结局
- Costs related to hospital visits(Baseline)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Every month, maximum 18 months)
- Patient satisfaction with remote monitoring or patient-initiated care(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)
- Daily steps(Through study completion, maximum 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)
- Sleep impairment(Baseline, 6, 12 and 18 months)
- Patient satisfaction with care(Baseline, 6, 12 and 18 months)
- Concomitant medication(Baseline, 6, 12 and 18 months)
- Heel enthesitis(Baseline, through study completion, and 18 months)
- Patient-reported self-efficacy for using different digital devices, secure login and digital health services measured on a Likert scale(Baseline)
- 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)
- Patient-reported flare(3, 6, 9, 12, 15 and 18 months)
- 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)
- 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)
- 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)
- Preferred follow-up strategy(18 months)
- Ankylosing Spondylitis Disease Activity Score (ASDAS)(Baseline, 6, 12 and 18 months)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline, 6, 12 and 18 months)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline, 3, 6, 9, 12, 15 and 18 months)
- Patient global assessment of disease activity(Baseline, 6, 12 and 18 months)
- Patient global assessment of disease activity(Every month, maximum 18 months)
- Patient-reported flare(6, 12 and 18 months)
- Patient-reported flare(Every month, maximum 18 months)
- Swollen joint count(Baseline, 6, 12 and 18 months)
- Tender joint count(Baseline, 6, 12 and 18 months)
- Heel enthesitis(Baseline, 6, 12 and 18 months)
研究者
Nina Osteras
Principal investigator
Diakonhjemmet Hospital