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

在2019冠状病毒病大流行之前，心脏手术后的恢复是通过让患者参与康复过程来优化的，康复过程分阶段进行：* 第一阶段是在手术后的床边。第二阶段为门诊 * 第三阶段为一系列运动锻炼和生活方式教育课程，为期6-8周（由护士和/或物理治疗师进行）。第三阶段的一些班级在医院，另一些在休闲中心。然后，患者被转介到第四阶段课程，通常在休闲中心。这些都是由英国心血管疾病预防和康复协会（BACPR）培训高标准的个人健康教练（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III期课程是免费的，但只有50%的合格患者参加。国家心脏康复审计发现，妇女、低收入背景的人和少数族裔群体不太可能参加这些改变生活的方案，由于这一流行病，所有面对面的康复过程都已停止。一线医护人员已被转移到支持新冠肺炎患者的治疗，没有多余的能力为心脏手术或心脏手术后恢复的患者提供服务。主动+我可以显着提高这些脆弱的患者的恢复，否则他们在自我隔离期间将获得最少的支持。Active+me将提供远程和自我监测、远程教育交付、远程锻炼课程和虚拟聊天室。在心脏手术后，Active+me将为脆弱、目前自我隔离且通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仅为10%，但影响患者健康的其他疾病的风险很高（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，包括远程监控服务，提供社区感，同时将NHS工作人员释放到一线职责。妇女、族裔群体、低收入病人和农村地区的病人尚未充分参与。Active+me现在可以远程交付，应用Aseptika开发的“自我护理六大支柱”：1.教育;2.体育锻炼（心血管/肌肉强化/平衡）;3.通过“轻触式”远程监测自我监测症状/生理体征的工具;4.药物依从性;5.学习触发器，和6.由家人、同伴和非医疗导师支持的长期行为改变（“轻触”行为改变理论）。需要Innovate UK提供资金，以支持Active+ me的推出。其他信息-在成功完成与Addenbrooke医院的Active+me REMOTE心脏恢复项目后（剑桥大学医院NHS基金会信托），该公司已经启动了一项新版本Activ 8 rlives应用程序的开发计划，以支持患者从名为Active+的心脏手术中恢复过来。远程恢复AP.这是我们于2020年8月完成的COVID-19快速应对项目的直接结果。随着英国完成离开欧盟的过渡期，一项新的监管标准将适用于在英国使用的医疗器械，称为UKCA。此次扩展的资金支持Aseptika在欧盟CE认证（根据MDR 2017/745）和美国FDA批准的同时实施这一新标准。

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.