Hypertension Clinical Trial
— eCardioCovid19Official 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
NCT number | NCT04325867 |
Other study ID # | GTP0032 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 31, 2020 |
Est. completion date | October 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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | October 1, 2020 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - all known cardiovascular patients from local Cardiology Clinics, with: 1. all spectrum of coronary syndromes (chronic to acute) +/- known coronary angioplasties; 2. treated arterial hypertension; 3. known congestive heart failure - AND isolated / quarantined recommendations (due to COVID 19 pandemic). Exclusion Criteria: - refusal / denial to create an electronic account on this dedicated platform; - refusal to accept wearable devices (ecg watches, oximetry). |
Country | Name | City | State |
---|---|---|---|
Romania | Medical Sciences Academy | Bucharest | |
Romania | University of Medicine and Pharmacy Gr T Popa | Iasi |
Lead Sponsor | Collaborator |
---|---|
Professor Adrian Covic | Medical Sciences Academy - Romania, Victor Babes Clinical Hospital of Infectious Diseases - Bucharest |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Number of consultations/sessions given | Will be the number of sessions per patient multiplied with the number of patients included | 6 months |
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