Integrated Distance Management Strategy for Patients With Cardiovascular Diseases in the Context of COVID-19

NCT04325867 | Unknown DMC

• 1 other identifier: GTP0032
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Angina Pectoris; Acute Coronary Syndrome; Coronary Syndrome; Coronary Artery Disease; Angioplasty; Stent Restenosis; Hypertension; Heart Failure, Systolic; Depression, Anxiety; Covid-19; Isolation, Social

Keywords

e-Health; Tele-Medicine; Remote medical surveillance; psychological counseling

Outcome Measures

Primary Outcomes (2)

• Providing a special electronic platform (e-health) for remote managing cardiovascular outpatients

  Development of an electronic (e-HEALTH) framework structure for management of patients with known cardiovascular disease in COVID19 pandemic social context

  6 months

• Number of patients included in this platform

  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);

  6 months

Secondary Outcomes (1)

• Number of consultations/sessions given

  6 months

Study Arms (1)

All patients with known cardiovascular disease

EXPERIMENTAL

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

Interventions

Tele-medicine platform OTHER

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).

All patients with known cardiovascular disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• refusal / denial to create an electronic account on this dedicated platform;
• refusal to accept wearable devices (ecg watches, oximetry).

Sponsors & Collaborators

• Professor Adrian Covic: lead
• Medical Sciences Academy - Romania: collaborator
• Victor Babes Clinical Hospital of Infectious Diseases - Bucharest: collaborator

Study Sites (2)

Medical Sciences Academy

Bucharest, Romania

RECRUITING

University of Medicine and Pharmacy Gr T Popa

Iași, 700503, Romania

RECRUITING

MeSH Terms

Conditions

Angina Pectoris; Acute Coronary Syndrome; Angina, Unstable; Coronary Artery Disease; Hypertension; Heart Failure, Systolic; Depression; Anxiety Disorders; COVID-19; Social Isolation

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Heart Failure; Behavioral Symptoms; Behavior; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Social Behavior

Study Officials

• Alexandru Burlacu, MD, PhD

  University of Medicine and Pharmacy "Gr. T. Popa" Iasi, Romania

  PRINCIPAL INVESTIGATOR

• Cristina Plesoianu, PhD

  Medical Sciences Academy from Romania

  STUDY DIRECTOR

Central Study Contacts

Alexandru Burlacu, MD, PhD

CONTACT

0040744488580; alexandru.burlacu@umfiasi.ro

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Vice-rector

Model Details: All patients with severe cardiovascular disease benefit from this project

Study Record Dates

• First Submitted: March 21, 2020
• First Posted: March 30, 2020
• Study Start: March 31, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: April 1, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

RO (2)