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COVID-19 Related Lockdown Effects On Chronic Diseases

COVID-19 Related Lockdown Effects On Chronic Diseases

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04390126
Acronym
CLEO-CD
Enrollment
1343
Registered
2020-05-15
Start date
2020-04-14
Completion date
2020-06-02
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERlife questionnaires

Telephone survey during the confinement period (common questionnaire and a questionnaire specific to the patient's pathology)

OTHERquestionnaire

1-year telephone diary to identify complications resulting in hospitalization related to the patient's chronic disease

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
9 Months to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
% adherence to each pharmacological classduring the period from 20 April 2020 to 7 May 2020increase in dose, decrease in dose, discontinuation or no change for each drug class)
number of occurrence of medical events at 1 yearthroughout the study for 12 months(mortality, hospitalizations and relevant criteria for each pathology all related to the chronic disease)

Secondary

MeasureTime frameDescription
Expressed in %: Non-pharmacological treatment/lifestyle:during the period from 20 April 2020 to 7 May 2020Smoking/Smoking/sweetening, Alcohol consumption/recovery, Decreased physical activity, Weight change
Expressed in %: Difficulties accessing care: medical appointments, prescriptions, medicationduring 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026