Clinical trial NCT04390126: COVID-19 Related Lockdown Effects On Chronic Diseases
Official title: COVID-19 Related Lockdown Effects On Chronic Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Coronary Syndrome
Heart Failure
AMD and Macular Edema
Chronic Respiratory Failure
Hemophilia
Malignant Hemopathy
Multiple Sclerosis
Horton's Disease
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 1200
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients from existing registries or cohorts

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.


Eligibility 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

Primary outcomes:
measure: % adherence to each pharmacological class
timeFrame: during the period from 20 April 2020 to 7 May 2020
measure: number of occurrence of medical events at 1 year
timeFrame: throughout the study for 12 months
Secondary outcomes:
measure: Expressed in %: Non-pharmacological treatment/lifestyle:
timeFrame: during the period from 20 April 2020 to 7 May 2020
measure: Expressed in %: Difficulties accessing care: medical appointments, prescriptions, medication
timeFrame: during the period from 20 April 2020 to 7 May 2020
measure: Measurement of psychological distress: Kessler's specific questionnaire (score between 0 and 24)
timeFrame: during the period from 20 April 2020 to 7 May 2020
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
citation: Boulin M, Cransac-Miet A, Maynadie M, Volot F, Creuzot-Garcher C, Eicher JC, Chague F, Ksiazek E, Beltramo G, Bonniaud P, Moreau T, Bonnotte B, Sales-Wuillemin E, Soudry-Faure A, Zeller M, Cottin Y. COVID-19 Lockdown in Patients with Chronic Diseases: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Mar 26;19(7):3957. doi: 10.3390/ijerph19073957.
citation: Volot F, Soudry-Faure A, Callegarin A, Ksiazek E, Delienne S, Cottin Y, Maynadie M, Boulin M. Impact of first COVID-19 lockdown on paediatric and adult haemophilia patients treated in a French Haemophilia Comprehensive Care Centre. Haemophilia. 2022 May;28(3):462-471. doi: 10.1111/hae.14526. Epub 2022 Mar 3.