Deployment of Active+me for remote patient support and cardiac rehabilitation for vulnerable patients in isolation, following heart surgery.

在新冠肺炎大流行之前，心脏手术后的康复是通过让患者参与康复过程来优化的，康复过程分阶段安排：*手术后在床边进行第一阶段。*第二阶段作为门诊患者*第三阶段，即为期6-8周的一系列运动锻炼和生活方式教育课程(由护士和/或物理治疗师进行)。一些第三阶段的课程在医院，其他的在康乐中心。*病人随后被转介到第四阶段的课程，通常是在康乐中心。这些项目由英国心血管预防和康复协会(BACPR)高标准培训的个人健康教练(PHCS)监督。完成第三阶段计划已被证明对健康有益，并由NICE强制执行。尽管第三阶段课程是免费的，但只有50%的符合条件的患者参加了培训。国家心脏康复审计发现，女性、低收入家庭和少数民族不太可能加入这些改变生活的项目。由于疫情的流行，所有面对面的康复过程都已经停止。前线护理人员已被转用来支持新冠肺炎患者的治疗，心脏手术或心脏手术后康复的患者没有多余的人员。Active+Me可以显著促进这些脆弱患者的康复，否则他们在自我隔离期间将获得最低限度的支持。Active+Me将提供远程和自我监控、远程教育、远程锻炼课程和虚拟聊天室。在进行心脏手术后，Active+Me将为脆弱、目前自我隔离且经常患有多种疾病的患者提供支持。虽然第二次心脏病发作的风险只有10%，但其他影响患者健康的情况的风险很高(50%)。Active+Me解决了用远程提供的新型“激活”服务取代面对面康复计划的主要挑战，该服务包括远程监控服务，提供社区意识并实现这一点，同时释放NHS工作人员到一线工作。英国每年有121,500名患者有资格接受心脏康复。妇女、族裔群体、低收入患者和农村环境中的患者尚未充分参与。Active+Me现在可以远程提供，应用ASeptika开发的“自我护理的六大支柱”：1.教育；2.体育锻炼(心血管/肌肉强化/平衡)；3.通过“轻触”远程监测自我监测症状/生理体征的工具；4.用药依从性；5.学习触发因素，以及6.由家庭支持的长期行为改变，同行和非医疗导师(“轻触”行为改变理论)。需要来自创新英国的资金来支持Active+me.------------------------------------------------ADDITIONAL INFORMTION----------------------------------------的推出-在成功完成与Addenbrooke‘s Hospital(剑桥大学医院NHS基金会信托基金)的Active+Me远程心脏恢复项目后，该公司已经启动了新版Activ8rLives应用程序的开发计划，以支持从名为Active+Me Remote Recovery AP的心脏手术中恢复的患者。这是我们的新冠肺炎快速反应项目的直接结果，该项目于2020年8月完成。由于现在预计会有多波新冠肺炎病毒，这一新产品的交付变得更加紧迫。随着英国完成退出欧盟的过渡期，一项名为UKCA的新监管标准将应用于在英国使用的医疗器械。此次延期的资金支持ASeptika在欧盟CE标志(根据MDR 2017/745)和FDA对美国的批准的同时，也实施了这一新标准。

Prior to the Covid-19 pandemic, recovery after heart surgery was optimised by engaging the patient in a rehabilitation process, arranged in stages:* Phase I at the bedside after the procedure.* Phase II as an out-patient* Phase III as a series of exercise workouts and lifestyle education classes over 6-8 weeks (conducted by nurses and/or physiotherapists). Some Phase III classes were in hospitals, others in leisure centres.* Patients were then referred to Phase IV classes, usually in leisure centres. These are supervised by Personal Health Coaches (PHCs) trained to high standards by the British Association for Cardiovascular Prevention and Rehabilitation (BACPR).Completing a Phase III programme has proven health benefits and is mandated by NICE. Even though the Phase III classes were free, only 50% of eligible patients enrolled. The National Audit of Cardiac Rehabilitation found that women, people from low-income backgrounds and those from ethnic groups were less likely to join these life-changing programmes.Due to the pandemic, all face-to-face rehabilitation processes have ceased. Front-line care-staff have been diverted to support the treatment of patients with Covid-19 and there is no spare capacity for patients recovering from heart surgery or a heart procedure. Active+me can significantly enhance recovery of these vulnerable patients, who will otherwise have minimal support during their self-isolation. Active+me will provide remote and self-monitoring, remote education delivery, remote exercise classes and virtual chat rooms.Following a heart procedure, Active+me will support patients who are vulnerable, currently self-isolated and often have multiple medical conditions. While the risk of a second heart attack is only 10%, the risks from other conditions affecting the health of the patient is high (50%). Active+me addresses the major challenge of replacing face-to-face rehabilitation programmes with a novel "activation" service which is delivered remotely, includes a remote monitoring service, delivers a sense of community and achieves this whilst releasing NHS staff to front-line duties.121,500 patients in the UK each year are eligible for Cardiac Rehabilitation. Women, ethnic groups, patients on low-incomes and those in rural settings have not been fully engaged. Active+me can now be delivered remotely, applying "the six pillars of self-care" developed by Aseptika:1. Education;2. Physical exercise (cardiovascular/muscle strengthening/balance);3. Tools to self-monitor symptoms/physiological signs with "light-touch" remote monitoring;4. Medication adherence;5. Learning triggers, and6. Long-term behaviour change supported by family, peers and non-medical mentors ("light touch" Behaviour Change Theory).Funding from Innovate UK is required to support roll-out of Active+me.------------------------------------------------ADDITIONAL INFORMTION------------------------------------------------After successfully completing the Active+me REMOTE Cardiac Recovery project with Addenbrooke’s Hospital (Cambridge Universities Hospital NHS Foundation Trust), a development programme for a new version of our Activ8rlives App has been started by the company to support patients recovering from a heart procedure called Active+me REMOTE Recovery Ap. This was a direct outcome of our COVID-19 rapid response project which was completed in August 2020.The delivery of this new product has become ever more urgent as multiple waves of the COVID-19 virus are now anticipated. As the UK completes the transition period to leave the EU, a new regulatory standard will be applied to medical devices which are used in the UK called UKCA. Funding from this extension supports Aseptika to also implement this new standard alongside its CE mark for the EU (under MDR 2017/745) and FDA approvals for the USA.