COVID-19 Related Lockdown Effects On Chronic Diseases

• Conditions: Heart Failure; Horton's Disease; Chronic Respiratory Failure; Malignant Hemopathy; AMD and Macular Edema; Chronic Coronary Syndrome; Hemophilia; Multiple Sclerosis
• Interventions: Other: life questionnaires; Other: questionnaire

• Registration Number: NCT04390126
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-20
• Status Verified: 2020-05
• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-15
• Last Update Submitted: 2021-01-19
• Last Update Posted: 2021-01-20
• Primary Completion: 2021-05-07
• Study Completion: 2021-11-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
% adherence to each pharmacological class	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)
number of occurrence of medical events at 1 year	throughout the study for 12 months	(mortality, hospitalizations and relevant criteria for each pathology all related to the chronic disease)

Secondary Outcome Measures

Name	Time	Method
Expressed in %: Non-pharmacological treatment/lifestyle:	during the period from 20 April 2020 to 7 May 2020	Smoking/Smoking/sweetening, Alcohol consumption/recovery, Decreased physical activity, Weight change
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

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France