Clinical Trials Directory

Trials / Completed

CompletedNCT04390126

COVID-19 Related Lockdown Effects On Chronic Diseases

Status
Completed
Phase
Study type
Observational
Enrollment
1,343 (actual)
Sponsor
Centre Hospitalier Universitaire Dijon · Academic / Other
Sex
All
Age
9 Months
Healthy volunteers
Not accepted

Summary

The containment associated with the VIDOC-19 pandemic creates an unprecedented societal situation of physical and social isolation. Our hypothesis is that in patients with chronic diseases, confinement leads to changes in health behaviours, adherence to pharmacological treatment, lifestyle rules and increased psychosocial stress with an increased risk of deterioration in their health status in the short, medium and long term. Some messages about the additional risk/danger associated with taking certain drugs in the event of COVID disease have been widely disseminated in the media since March 17, 2020, the date on which containment began in France. This is the case, for example, for corticosteroids, non-steroidal anti-inflammatory drugs but also for converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor antagonists (ARBs2). These four major classes of drugs are widely prescribed in patients with chronic diseases, diseases specifically selected in our study (corticosteroids: haematological malignancies, multiple sclerosis, Horton's disease; ACE inhibitors/ARAs2: heart failure, chronic coronary artery disease). Aspirin used at low doses as an anti-platelet agent in coronary patients as a secondary prophylaxis after a myocardial infarction can be stopped by some patients who consider aspirin to be a non-steroidal anti-inflammatory drug. Discontinuation of this antiplatelet agent, which must be taken for life after an infarction, exposes the patient to a major risk of a new cardiovascular event. The current difficulty of access to care due to travel restrictions (a theoretical limit in the context of French confinement but a priori very real), the impossibility of consulting overloaded doctors, or the cancellation of medical appointments, medical and surgical procedures due to the reorganization of our hospital and private health system to better manage COVID-19 patients also increases the risk of worsening the health status of chronic patients who by definition require regular medical monitoring. Eight Burgundian cohorts of patients with chronic diseases (chronic coronary artery disease, heart failure, multiple sclerosis, Horton's disease, AMD, haemopathic malignancy, chronic respiratory failure (idiopathic fibrosis, PAH) haemophilia cohort) will study the health impact of the containment related to the COVID-19 pandemic.

Conditions

Interventions

TypeNameDescription
OTHERlife questionnairesTelephone survey during the confinement period (common questionnaire and a questionnaire specific to the patient's pathology)
OTHERquestionnaire1-year telephone diary to identify complications resulting in hospitalization related to the patient's chronic disease

Timeline

Start date
2020-04-14
Primary completion
2020-06-02
Completion
2020-06-02
First posted
2020-05-15
Last updated
2026-02-02

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04390126. Inclusion in this directory is not an endorsement.