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COVID-19 Related Lockdown Effects On Chronic Diseases (CLEO-CD)

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

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

Treatments

Other: questionnaire
Other: life questionnaires

Study type

Observational

Funder types

Other

Identifiers

NCT04390126
BOULIN AOIc 2020

Details and patient eligibility

About

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.

Enrollment

1,343 patients

Sex

All

Ages

9+ months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients with one of the following chronic diseases: chronic coronary syndrome, heart failure, multiple sclerosis, Horton's disease, AMD, malignant haemopathy, chronic respiratory failure (idiopathic fibrosis, PAH, haemophilia) and already registered in one of the 8 Burgundian registries/cohorts.

Exclusion criteria

  • deceased patient, patient cannot be reached after >3 telephone calls, patient or caregiver does not speak French to carry out telephone interviews

Trial design

1,343 participants in 8 patient groups

Register of haematological malignancies
Treatment:
Other: life questionnaires
Other: questionnaire
Idiopathic Pulmonary Fibrosis and PAH Cohort
Treatment:
Other: life questionnaires
Other: questionnaire
Giant Cell Arteritis Cohort
Treatment:
Other: life questionnaires
Other: questionnaire
AMD and Macular Edema Cohort
Treatment:
Other: life questionnaires
Other: questionnaire
Multiple Sclerosis Cohort
Treatment:
Other: life questionnaires
Other: questionnaire
Myocardial Infarction Observatory RICO
Treatment:
Other: life questionnaires
Other: questionnaire
Heart Failure Cohort
Treatment:
Other: life questionnaires
Other: questionnaire
Hemophilia Cohort
Treatment:
Other: life questionnaires
Other: questionnaire

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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