Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,343

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 months study duration

Study Start

First participant enrolled

April 14, 2020

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

May 14, 2020

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed

18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2020

Completed

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

May 14, 2020

Last Update Submit

January 29, 2026

Conditions

Chronic Coronary Syndrome Heart Failure AMD and Macular Edema Chronic Respiratory Failure Hemophilia Malignant Hemopathy Multiple Sclerosis Horton's Disease

Outcome Measures

Primary Outcomes (2)

% adherence to each pharmacological class
increase in dose, decrease in dose, discontinuation or no change for each drug class)
during the period from 20 April 2020 to 7 May 2020
number of occurrence of medical events at 1 year
(mortality, hospitalizations and relevant criteria for each pathology all related to the chronic disease)
throughout the study for 12 months