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

January 19, 2021 updated by: Centre Hospitalier Universitaire Dijon

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • Chu Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients from existing registries or cohorts

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% 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)
during the period from 20 April 2020 to 7 May 2020
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)
throughout the study for 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during the period from 20 April 2020 to 7 May 2020
Expressed in %: Difficulties accessing care: medical appointments, prescriptions, medication
Time Frame: during the period from 20 April 2020 to 7 May 2020
during the period from 20 April 2020 to 7 May 2020
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
during the period from 20 April 2020 to 7 May 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2020

Primary Completion (Anticipated)

May 7, 2021

Study Completion (Anticipated)

November 7, 2021

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (Actual)

May 15, 2020

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 19, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOULIN AOIc 2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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