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

• ClinicalTrials.gov Identifier: NCT04390126
• Recruitment Status: Active, not recruiting
• First Posted: May 15, 2020
• Last Update Posted: January 20, 2021
• Sponsor: Centre Hospitalier Universitaire Dijon
• Information provided by (Responsible Party): Centre Hospitalier Universitaire Dijon

Study Description

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.

Condition or disease	Intervention/treatment
Chronic Coronary Syndrome; Heart Failure; AMD and Macular Edema; Chronic Respiratory Failure; Hemophilia; Malignant Hemopathy; Multiple Sclerosis; Horton's Disease	Other: life questionnaires; Other: questionnaire

Study Design

• Study Type: Observational
• Actual Enrollment: 1200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: COVID-19 Related Lockdown Effects On Chronic Diseases
• Actual Study Start Date: April 20, 2020
• Estimated Primary Completion Date: May 7, 2021
• Estimated Study Completion Date: November 7, 2021

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 9 Months and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

patients from existing registries or cohorts

Criteria

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

Contacts and Locations

Locations

France

CHU Dijon Bourgogne

Dijon, France, 21079

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

More Information

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT04390126
• Other Study ID Numbers: BOULIN AOIc 2020
• First Posted: May 15, 2020
• Last Update Posted: January 20, 2021
• Last Verified: May 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Polymyalgia Rheumatica; Respiratory Insufficiency; Multiple Sclerosis; Giant Cell Arteritis; Macular Edema; Chronic Disease; Cardiovascular Diseases; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Respiration Disorders; Respiratory Tract Diseases; Disease Attributes; Vasculitis, Central Nervous System; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases