A Randomised, Two-arm, Parallel-assigned Open-label Standard-of-care Controlled Trial to Investigate the Efficacy of Using the Remote Patient Monitoring Platform DETECTRA to Shorten Time-to-diagnosis of Rheumatoid Arthritis in At-risk Patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 142
- 试验地点
- 5
- 主要终点
- Time-to-diagnosis
研究概览
简要总结
The goal of this clinical trial is to learn if a remote monitoring application called DETECTRA can help doctors diagnose rheumatoid arthritis earlier in people who are at risk of developing the disease. It will also learn about the safety and usefulness of this approach.
The main questions it aims to answer are:
Does monitoring symptoms through the DETECTRA application help doctors diagnose rheumatoid arthritis earlier than standard medical follow-up? Does the use of the application help doctors identify signs of arthritis and arrange a medical consultation sooner? How does the disease progress in participants, and how well are their symptoms controlled?
A total of 142 adults will take part in the study. Participants will be randomly assigned to one of two groups:
- Receive standard medical care
- Receive standard medical care and use the DETECTRA application
Participants using the application will:
Answer questions about their symptoms every 2 weeks Take photographs of their hands using their smartphone Have their information reviewed remotely by doctors
The study will also look at how participants use the application and whether remote monitoring could be useful for the healthcare system.
详细描述
The Pix-Risk study is an international clinical trial investigating whether a remote monitoring application called DETECTRA can help diagnose rheumatoid arthritis earlier in people who are at risk of developing the disease. These patients have recently developed joint pain and have a positive blood test indicating an increased risk, but they have not yet been diagnosed with the disease.
A total of 142 adults will participate in the study. They will be randomly assigned to two groups: one group will receive standard medical care, while the other will have access to the DETECTRA application in addition to standard care. Every two weeks, participants using the application will be asked to answer a few questions about their symptoms and take photographs of their hands using their smartphone. Doctors will be able to review this information remotely to identify signs of arthritis at an earlier stage and arrange a consultation if necessary.
The main objective is to determine whether this digital monitoring approach allows rheumatoid arthritis to be diagnosed more quickly than standard follow-up. The researchers will also assess disease progression, symptom control, use of the application, and its potential benefits for the healthcare system.
The study involves minimal risks, as it primarily relies on questionnaires, photographs, and routine medical examinations. The aim is to improve the early detection of the disease so that treatment can be started earlier and joint damage can be reduced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Must provide and sign the study's Informed Consent prior to any study-related procedures
- •Able to understand and interact with the study team
- •Agree to comply in good faith with all conditions of the recordings, and to attend all required study procedures.
- •Arthralgia (including hand joints PIP and or MCP)
- •Joint symptoms (arthralgia or stiffness) of recent onset (symptoms <1 year)
- •Known positive ACPA-titer with written proof
- •Aged 18 years-old or more
排除标准
- •Deformation of the hands or patients who have undergone joint arthrodesis or arthroplasty
- •Known microcrystal disease (e.g. gout, calcium pyrophosphate deposition) if hands are affected or pre-existing immune-mediated rheumatic diseases such as systemic lupus erythematosus or Sjögren's disease
- •Fulfilling the ACR/EULAR 2010 classification criteria for diagnosis of RA (≥ 6 points)
- •Known or suspected clinical synovitis by physician in > 3 small joints (with or without involvement of large joints)
- •Any previous b, ts, and csDMARDs use
- •Lymphoedema in arms or hands following an axillary lymph node dissection
- •Inability to provide written informed consent
- •Severe cognitive impairment, severe psychiatric conditions or other inability to follow the procedures of the study
- •Immunosuppressive therapy for other autoimmune conditions <2 years ago
- •Any Immunosuppressive therapy for other autoimmune conditions with B-cell depletion
- •Haematological or oncological treatments involving induction and / or maintenance chemotherapy within the last 5 years are not permitted
- •Participation in another investigation with an investigational drug or another MD within the 30 days preceding the trial or currently participating or planning to participate in an interventional trial
- •No regular (at least every 2 weeks) access to a smartphone
- •Adults who lack capacity to consent, known pregnant and breastfeeding women
- •Subjects for whom routine examination of the musculoskeletal system is not possible, or whose hands cannot be imaged (e.g., bandages that cannot be removed for hand picture taking, or injuries affecting the PIP joints both persisting for > 49 days)
- •Enrolment of the PI, his/her family members, employees and other dependent persons
研究组 & 干预措施
Control group
Standard-of-care
干预措施: Standard of Care (SOC) (Other)
DETECTRA
The intervention group will receive the DETECTRA application on top of the standard-of-care and will use it every two weeks to upload hand images and report patient reported outcomes.
干预措施: DETECTRA (Device)
结局指标
主要结局
Time-to-diagnosis
时间窗: From study enrollement to confirmed clinical diagnosis
Time (in days) from study enrollment to confirmed clinical diagnosis of rheumatoid arthritis (with the ACR/EULAR 2010 classification criteria for RA (≥ 6 points) and / or physician diagnosis with start of DMARDs) in ACPA-positive arthralgia patients, comparing the DETECTRA group to the standard-of-care group.
次要结局
- Difference in DAS28-CRP and SDAI(From study enrollement until the end of the study (24months))
- Remission rates(From study enrollement until the end of study (24months))
- Sensitivity(From study enrollement until the end of study (24months))
- Specificity(From enrolement until the end of study (24months).)
- Adherence(From study enrollement until diagnosis or end of study (24months))
- Adherence(From enrolement until end of study (24months) or until diagnosis of RA.)
- Cost-effectiveness estimates(Full study duration (24months))
研究者
Thomas Hügle
Prof. Dr. Thomas Hügle - Head of departement
Centre Hospitalier Universitaire Vaudois