Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04390126
Recruitment Status : Active, not recruiting
First Posted : May 15, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
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.


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

Layout table for study information
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

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390126


Locations
Layout table for location information
France
CHU Dijon Bourgogne
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT04390126    
Other Study ID Numbers: BOULIN AOIc 2020
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: May 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for 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