Integrated Distance Management Strategy for Patients With Cardiovascular Disease (Ischaemic Coronary Artery Disease, High Blood Pressure, Heart Failure) in the Context of the COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Providing a special electronic platform (e-health) for remote managing cardiovascular outpatients
研究概览
简要总结
Management of known patients with cardiovascular disease (in particular the whole spectrum of atherosclerotic ischaemic coronary artery disease, essential hypertension under treatment, and also patients with chronic heart failure under medication) and with other associated chronic pathologies, with obvious effects on the management of the pandemic with modern / distance means (e-Health) of patients at high risk of mortality in contact with coronavirus.
Given the Covid-19 Pandemic, all the above complex cardiovascular patients are under the obligation to stay in the house isolated and can no longer come to standard clinical and paraclinical monitoring and control visits. Therefore, a remote management solution (tele-medicine) of these patients must be found.
The Investigators endeavour is to create an electronic platform to communicate with these patients and offer solutions for their cardiovascular health issues (including psychological and religious problems due to isolation).
The Investigators intend to create this platform for communicating with a patient and stratify their complaints in risk levels. A given specialist will sort and classify their needs on a scale, based on specific algorithms (derived from the clinical European Cardiovascular Guidelines), and generate specific protocols varying from 911 like emergencies to cardiological advices or psychological sessions. These could include medication changing of doses, dietary advices or exercise restrictions. Moreover, in those patients suspected of COVID infection, special assistance should be provided per protocol.
详细描述
Specific objective 1: Establishing the risk profile of the patient with cardiovascular disease
Specific objective 2: Development of an electronic (e-HEALTH) framework structure for management of patients with known cardiovascular disease in COVID19 pandemic social context
(Cardiology specialists, interventional cardiology, cardiovascular surgery, oncology, infectious diseases, diabetologists, family doctors, psychologists / psychiatrists, priests and religious advisors).
- the patient is included in the AngioNET research database and automatically creates an account on the M platform and gives the consent for the data transfer on the platform or the patient registers directly on the M platform and uploads his medical data (analysis and imaging) to his personal account;
- patients complete the section with data specific to the coronavirus pandemic;
- the patients select the type of consultation they request and they are redirected to specific sections with dedicated multidisciplinary teams;
- patients come into direct contact with the case coordinator, who provides ongoing assistance, including for connecting to devices that ensure real-time data transmission and directing to specialist teams that establish stage diagnosis and management / therapy behavior (including adjustment). doses, decisions to discontinue medication or to add medication);
- the classification of patients in emergency categories and the follow-up of specific trajectories:
- 1 - 911 for transporting patients to the hospital in an emergency (for cardiovascular emergencies or COVID symptoms);
- 2 - adjusted drug therapy, followed by accelerated monitoring for periodic evaluations in order to decide to pass in category 1 or 3;
- 3 - establishing drug treatment and monitoring. Over all these categories, specific protection measures in the case of coronavirus infection overlap
- monitoring the short and medium term evolution of patients in isolation (vital parameters, transmitted through the provided wireless devices)
- Detailed / and largely based protocols will be developed based on the recommendations of the Guidelines, but also on the experts' opinion and on the local expertise (pandemic, national emergency) for at least three categories.
Deliverables for specific objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all known cardiovascular patients from local Cardiology Clinics, with:
- •all spectrum of coronary syndromes (chronic to acute) +/- known coronary angioplasties;
- •treated arterial hypertension;
- •known congestive heart failure
- •AND isolated / quarantined recommendations (due to COVID 19 pandemic).
排除标准
- •refusal / denial to create an electronic account on this dedicated platform;
- •refusal to accept wearable devices (ecg watches, oximetry).
研究组 & 干预措施
All patients with known cardiovascular disease
All these patients will be provided an electronic account on a dedicated platform were they can be supervised and can call for advice / help.
This kind of tele-medical project aims to keep these patients in a so-called proximity, monitoring their vital parameters, checking their medication and providing dedicated advices according to their complaints.
Moreover, all these patients will receive digital watches with ecg-recording capabilities, thus a dedicated physician could correlate their symptoms with few clear paraclinical variables.
All of these patients' complaints will be stratified according to elaborated protocols based on the European Cardiovascular Guidelines.
Moreover, a psychologist and a chaplain will deal with their (new) problems due to social isolation.
干预措施: Tele-medicine platform (Other)
结局指标
主要结局
Providing a special electronic platform (e-health) for remote managing cardiovascular outpatients
时间窗: 6 months
Development of an electronic (e-HEALTH) framework structure for management of patients with known cardiovascular disease in COVID19 pandemic social context
Number of patients included in this platform
时间窗: 6 months
patients come into direct contact with the case coordinator, who provides ongoing assistance, including for connecting to devices that ensure real-time data transmission and directing to specialist teams that establish stage diagnosis and management / therapy behavior (including adjustment). doses, decisions to discontinue medication or to add medication);
次要结局
- Number of consultations/sessions given(6 months)
研究者
Professor Adrian Covic
Professor, Vice-rector
Grigore T. Popa University of Medicine and Pharmacy