COVID-19 Related Lockdown Effects On Chronic Diseases

Study Overview
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Brief Summary
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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.

Official Title
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COVID-19 Related Lockdown Effects On Chronic Diseases

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

Intervention / Treatment
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* Other: life questionnaires
* Other: questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Register of haematological malignancies<br> | Other: life questionnaires<br>* Telephone survey during the confinement period (common questionnaire and a questionnaire specific to the patient's pathology)<br>Other: questionnaire<br>* 1-year telephone diary to identify complications resulting in hospitalization related to the patient's chronic disease<br>|
| Idiopathic Pulmonary Fibrosis and PAH Cohort<br> | Other: life questionnaires<br>* Telephone survey during the confinement period (common questionnaire and a questionnaire specific to the patient's pathology)<br>Other: questionnaire<br>* 1-year telephone diary to identify complications resulting in hospitalization related to the patient's chronic disease<br>|
| Giant Cell Arteritis Cohort<br> | Other: life questionnaires<br>* Telephone survey during the confinement period (common questionnaire and a questionnaire specific to the patient's pathology)<br>Other: questionnaire<br>* 1-year telephone diary to identify complications resulting in hospitalization related to the patient's chronic disease<br>|
| AMD and Macular Edema Cohort<br> | Other: life questionnaires<br>* Telephone survey during the confinement period (common questionnaire and a questionnaire specific to the patient's pathology)<br>Other: questionnaire<br>* 1-year telephone diary to identify complications resulting in hospitalization related to the patient's chronic disease<br>|
| Multiple Sclerosis Cohort<br> | Other: life questionnaires<br>* Telephone survey during the confinement period (common questionnaire and a questionnaire specific to the patient's pathology)<br>Other: questionnaire<br>* 1-year telephone diary to identify complications resulting in hospitalization related to the patient's chronic disease<br>|
| Myocardial Infarction Observatory RICO<br> | Other: life questionnaires<br>* Telephone survey during the confinement period (common questionnaire and a questionnaire specific to the patient's pathology)<br>Other: questionnaire<br>* 1-year telephone diary to identify complications resulting in hospitalization related to the patient's chronic disease<br>|
| Heart Failure Cohort<br> | Other: life questionnaires<br>* Telephone survey during the confinement period (common questionnaire and a questionnaire specific to the patient's pathology)<br>Other: questionnaire<br>* 1-year telephone diary to identify complications resulting in hospitalization related to the patient's chronic disease<br>|
| Hemophilia Cohort<br> | Other: life questionnaires<br>* Telephone survey during the confinement period (common questionnaire and a questionnaire specific to the patient's pathology)<br>Other: questionnaire<br>* 1-year telephone diary to identify complications resulting in hospitalization related to the patient's chronic disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expressed in %: Non-pharmacological treatment/lifestyle: | Smoking/Smoking/sweetening, Alcohol consumption/recovery, Decreased physical activity, Weight change | during the period from 20 April 2020 to 7 May 2020 | 
| Expressed in %: Difficulties accessing care: medical appointments, prescriptions, medication |  | during the period from 20 April 2020 to 7 May 2020 | 
| Measurement of psychological distress: Kessler's specific questionnaire (score between 0 and 24) |  | during the period from 20 April 2020 to 7 May 2020 |