Validation of the Synovo Digital Disease Activity Score (DDAS) Against Physician-Performed DAS28/CDAI: A Non-Clinical, Non-Interventional, Non-Academic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Correlation Between DDAS and Clinician-Derived DAS28
研究概览
简要总结
The goal of this observational study is to assess whether the Synovo digital assessment can measure rheumatoid arthritis disease activity in adults with rheumatoid arthritis.
The main questions it aims to answer are:
How closely does the Synovo digital disease activity score agree with the clinician-assessed DAS28 score?
Can the Synovo assessment identify changes in disease activity between follow-up visits?
Participants will:
Complete a structured digital questionnaire
Record guided videos of selected joint movements using a smartphone
Undergo a standard DAS28 assessment by a clinician during the same visit
Some participants may repeat the assessments at a later follow-up visit.
详细描述
Rheumatoid arthritis is a chronic inflammatory disease that can lead to pain, functional impairment, joint damage and disability. Evidence from tight-control and treat-to-target studies shows that structured and repeated measurement of disease activity, followed by timely clinical action, improves disease control and remission outcomes.
The Synovo DDAS combines patient-reported information with movement features derived from four guided smartphone videos. The system produces a continuous score calibrated to the DAS28 scale. The study evaluates the measured relationship between DDAS and clinician-derived DAS28. It does not assume interchangeability and does not test autonomous treatment decisions.
The study is designed to determine whether the DDAS demonstrates sufficient association, agreement and longitudinal tracking to justify further independent and multicenter validation. This is an exploratory, single-centre study intended to establish an initial clinical evidence base rather than definitive clinical interchangeability or regulatory-grade performance.
Primary objective: To assess the association between paired DDAS and clinician-derived DAS28 values.
Secondary objectives
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 years or older
- •Any sex or gender
- •Clinician-confirmed rheumatoid arthritis, consistent with established ACR/EULAR criteria or a documented routine-care diagnosis
- •Receiving routine care at Aap Ka Clinic during the study period
- •Able and willing to provide written informed consent
- •Able to complete the DDAS assessment independently or with reasonable non-clinical assistance
- •Access to a compatible smartphone or tablet and sufficient connectivity for video upload
排除标准
- •Younger than 18 years
- •Unable to provide informed consent
- •A non-rheumatoid condition that substantially prevents completion or interpretation of the guided movements
- •Unable to complete study procedures despite reasonable assistance
- •Concurrent participation in another interventional study where participation could affect the reference or index assessments
结局指标
主要结局
Correlation Between DDAS and Clinician-Derived DAS28
时间窗: At each paired assessment during the same clinical encounter.
Pearson correlation coefficient between paired Synovo Digital Disease Activity Score and clinician-derived DAS28 values, reported with a 95% confidence interval.
次要结局
- Numerical Agreement Between DDAS and DAS28(At each paired assessment during the same clinical encounter.)
研究者
Dr. Nasir Saleem Anwar Khan
Co-Founder, Synovo
Synovo Ltd.