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NCT Number: NCT04390126

COVID-19 Related Lockdown Effects On Chronic Diseases

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.

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Key information

Conditions

Chronic Coronary Syndrome AMD and Macular Edema Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Respiratory Failure Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Genetic Diseases, Inborn Giant Cell Arteritis Heart Diseases Heart Failure Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia Hemophilia A Hemorrhagic Disorders Horton's Disease Immune System Diseases Macular Degeneration Macular Edema Malignant Hemopathy Multiple Sclerosis Nervous System Diseases Retinal Degeneration Retinal Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

9 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

life questionnaires

Other

Telephone survey during the confinement period (common questionnaire and a questionnaire specific to the patient's pathology)

Questionnaire

Other

1-year telephone diary to identify complications resulting in hospitalization related to the patient's chronic disease

Primary outcomes

  1. % adherence to each pharmacological class

    Time frame: during the period from 20 April 2020 to 7 May 2020

    increase in dose, decrease in dose, discontinuation or no change for each drug class)

  2. number of occurrence of medical events at 1 year

    Time frame: throughout the study for 12 months

    (mortality, hospitalizations and relevant criteria for each pathology all related to the chronic disease)

Secondary outcomes

  1. Expressed in %: Non-pharmacological treatment/lifestyle:

    Time frame: during the period from 20 April 2020 to 7 May 2020

    Smoking/Smoking/sweetening, Alcohol consumption/recovery, Decreased physical activity, Weight change

  2. Expressed in %: Difficulties accessing care: medical appointments, prescriptions, medication

    Time frame: during the period from 20 April 2020 to 7 May 2020

  3. Measurement of psychological distress: Kessler's specific questionnaire (score between 0 and 24)

    Time frame: during the period from 20 April 2020 to 7 May 2020

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: CLEO-CD

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 15, 2020
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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