Home based digital urinalysis in antenatal pathway

Healthy.io将在皇家联合医院巴斯国民保健服务基金会信托基金会的100名妇女中测试基于智能手机的产前护理家庭尿检。我们的目标是评估智能手机支持的家庭尿液分析，结合家庭血压测量，如何通过蛋白尿的早期检测来提高患者的安全性，通过避免面对面的访问来减少对医疗服务的需求，并以具有成本效益和可扩展的方式改善患者体验。使用计算机视觉和以用户为中心的设计，Healthy.io的是第一家将智能手机摄像头变成临床级医疗设备的公司。我们的尿液分析产品（Dip.io）是首款获得CE认证和FDA批准的智能手机自动尿液分析设备。该设备围绕10参数试纸、自测套件和智能手机应用程序构建，使非专业用户能够在舒适的家中自测尿液中的蛋白质和其他分析物，而不会影响质量。我们的专有算法和基于云的服务允许与任何临床系统的互操作性和集成。结果可立即提供给临床医生进行随访。血压监测和尿液分析是常规产前护理的一部分。我们的“产妇护理箱”结合了我们的尿液分析测试套件和血压监测仪，使妇女能够在就诊前和就诊期间（如果需要）进行自我测试，并可靠地与助产士分享结果。该研究将从2019年7月开始持续12个月。将向70名无并发症怀孕妇女和30名高血压怀孕妇女提供产妇护理箱。他们将被指示在参加产前预约之前进行尿检和血压测量。高血压孕妇将获得额外的Dip.io测试套件，以增加预约之间的测试频率。将常规检测转移到家庭有可能：改善妇女的经验和参与他们的健康减少预约时间花费在常规检测，使助产士能够专注于临床和面向患者的活动。通过更频繁的家庭检测，以早期发现并发症（如先兆子痫），减轻风险妊娠的风险。减少高达60%的日评估单位访问所需的风险妊娠晚期（如果正常结果）。将电子结果直接嵌入临床记录。这种模式已在非NHS医疗保健设置实施，并收到了患者和临床医生的积极反馈。本研究将评估该模型在NHS环境中的可行性和可接受性，以产生证据，帮助扩大创新，进行产品改进，并测试由肯特萨里和苏塞克斯AHSN设计的预算影响模型。

Healthy.io will be testing smartphone-based home urine testing for antenatal care in 100 women in the Royal United Hospitals Bath NHS Foundation Trust. We aim to assess how smartphone-enabled home urinalysis, combined with home blood pressure measurement, improves patient safety through proteinuria earlier detection, reducing demand on health services by avoiding face-to-face visits and improving patient experience in a cost-effective and scalable way.Using computer vision and user-centric design, Healthy.io's is the first company to turn the smartphone camera into a clinical-grade medical device. Our urinalysis product (Dip.io) is the first CE accredited and FDA cleared smartphone-enabled automated urinalysis device. Built around the 10 parameter dipstick, a self-testing kit and a smartphone application, the device enables lay users to self-test for protein and other analytes in their urine, in the comfort of their home, with no quality compromise. Our proprietary algorithm and cloud-based service allow for interoperability and integration with any clinical system. Results are immediately available to clinicians for follow-up.Blood pressure monitoring and urinalysis are part of routine antenatal care. Our 'maternity care box' combines our urinalysis test kit and a blood pressure monitor enabling women to self-test before and if needed, between visits and reliably share results with their midwife.The study will last 12 months starting July 2019. A maternity care box will be offered to 70 women with uncomplicated pregnancies and 30 women with hypertensive pregnancies. They'll be instructed to conduct the urine test and BP measure before attending their antenatal appointment. Women with hypertensive pregnancies will receive additional Dip.io test kits to increase testing frequency between appointments. Shifting routine testing to the home has the potential to:Improve women's experience and involvement in their healthReduce appointment time spent on routine testing to enable midwives to focus on clinical and patient-facing activity.Mitigate against risks in at-risk pregnancies through more frequent home testing to early detect complications (e.g. preeclampsia).reduce up to 60% of Day Assessment Unit visits needed for at-risk pregnancies during the third trimester (if normal results).Embed electronic results directly into clinical record.This model has been implemented in non-NHS healthcare settings and has received positive feedback from both patients and clinicians. This study will evaluate the feasibility and acceptability of the model in an NHS setting, to generate evidence to help scale the innovation, make product improvements and test the Budget Impact Model designed by Kent Surrey & Sussex AHSN.