Hypertension Clinical Trial
Official title:
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
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.
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:
- functional management platform for patients with cardiovascular disease, bodily and
intangible assets necessary for the functioning of the platform;
- multidisciplinary teams with the reaction speed adapted to the specific of each case /
emergency category;
- emergency counseling schemes, including psychological and religious counseling;
- collection, interpretation and processing conclusions given in management optimization
policies for patients with cardiovascular diseases.
Specific objective 3: Procedures regarding interventions on categories classified by
cardiovascular emergencies
Activities for achieving the objective:
- elaboration of procedures on categories of emergencies in the presence of coronavirus:
1- urgent interventional / surgical / hybrid therapy; 2- short-term drug treatment for
the subsequent therapeutic intervention; 3 - drug treatment for cardiovascular pathology
doubled by coronavirus treatment
- follow-up for obtaining medical data, including epidemiological and related to the
environmental parameters at the place where the patient belongs and their processing for
the purpose of optimizing public health measures in patients with cardiovascular
diseases
Specific objective 4: Campaign to promote the distance management method through specific
e-Health methods to mitigate the psychological impact of using the distance diagnosis and
treatment and implementing the procedures
The social pressure brought about by isolation of patients who would otherwise have benefited
from frequent outpatient consultations for various problems, such as: adjusting doses of
antihypertensive treatment, managing sporadic chest pain, managing body weight and diuresis
in patients with heart failure, adjusting the schema, treatment based on heart rate and
diuretic doses, chronic oral anticoagulant treatment or management of supraventricular
tachyarrhythmias or extrasystolys at home.
In addition, isolation at home puts another kind of pressure (psychic in essence) on the
patients who are also suffering from the mentioned chronic pathology. These patients bring
the stress of isolation in relation to their own person, family / contacts, but also with the
medical team in possible digital / wireless contact.
At this time, there are no management protocols for patients with such a degree of
complexity, the telemetry problem being only isolated, as far as local resources and specific
objectives are concerned, in no case viewed in their entirety.
The major problem that arises with the isolation of these patients is that they cannot be
admitted to hospitals for problems of low severity compared to the current territorial
capacities, and at the same time, they cannot be left unattended - by abolishing / blocking
the medical activity in the specialized outpatient clinics. .
It cannot be said that there is similar experience with the current epidemiological situation
and there are no Guides or directions of institutionalized medical practice.
This particular situation more likely makes experts to witness an increase in the
complications of cardiovascular diseases through the lack of direct management (heart failure
compensations), early and long-term complications of tension jumps or uncontrolled tension
values, and possibly acute coronary syndromes).
Moreover, the coronary patients who are instrumented by stenting, see the impossibility to
come to the periodic checks at 1 month, 3 months, 6 months, 9 months and one year after the
coronary stenting, as there is no alternative solution to the closure of the outpatients.
Specific objective 5: Evaluation of the social, environmental and economic impact determined
by the proposed management system
- impact study: social (physical and mental health, religion contributions and
technological development in the studied patient profile structure, interaction with
public and private health and social institutions) and quantifying the influence of
atmospheric pollution factors on the studied patients, risk maps depending on patient
location;
- cost management model for the targeted patients, quantification of upstream and
downstream costs reduction, general impact on the costs in the health system, the social
system as well as the budget allocated from own sources by the patients / patients
involved.
;
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