Integrated Distance Management Strategy for Patients With Cardiovascular Diseases in the Context of COVID-19 (eCardioCovid19)
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|ClinicalTrials.gov Identifier: NCT04325867|
Recruitment Status : Recruiting
First Posted : March 30, 2020
Last Update Posted : April 1, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Angina Pectoris Acute Coronary Syndrome Coronary Syndrome Coronary Artery Disease Angioplasty Stent Restenosis Hypertension Heart Failure, Systolic Depression, Anxiety Covid-19 Isolation, Social||Other: Tele-medicine platform||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All patients with severe cardiovascular disease benefit from this project|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|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|
|Actual Study Start Date :||March 31, 2020|
|Estimated Primary Completion Date :||October 1, 2020|
|Estimated Study Completion Date :||October 1, 2020|
Experimental: 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.
Other: Tele-medicine platform
Electronic counselling of known pathology cardiovascular patients through a complex remote platform and dedicated experts. This project intend remote monitoring through wearable devices (e.g. ECG watches, pulse detectors, oximetry).
- Providing a special electronic platform (e-health) for remote managing cardiovascular outpatients [ Time Frame: 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 [ Time Frame: 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);
- Number of consultations/sessions given [ Time Frame: 6 months ]Will be the number of sessions per patient multiplied with the number of patients included
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04325867
|Contact: Alexandru Burlacu, MD, PhDfirstname.lastname@example.org|
|Medical Sciences Academy||Recruiting|
|Contact: Cristina Plesoianu, PhD 0040722270066 email@example.com|
|University of Medicine and Pharmacy Gr T Popa||Recruiting|
|Iasi, Romania, 700503|
|Contact: Alexandru Burlacu, MD, PhD 0040744488580 firstname.lastname@example.org|
|Principal Investigator:||Alexandru Burlacu, MD, PhD||University of Medicine and Pharmacy "Gr. T. Popa" Iasi, Romania|
|Study Director:||Cristina Plesoianu, PhD||Medical Sciences Academy from Romania|