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

Tracking Information

• First Submitted Date: May 14, 2020
• First Posted Date: May 15, 2020
• Last Update Posted Date: January 20, 2021
• Actual Study Start Date: April 20, 2020
• Estimated Primary Completion Date: May 7, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 14, 2020)

• % 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)
• 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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 14, 2020)

• 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
• Expressed in %: Difficulties accessing care: medical appointments, prescriptions, medication [ Time Frame: 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: COVID-19 Related Lockdown Effects On Chronic Diseases
• Official Title: COVID-19 Related Lockdown Effects On Chronic Diseases

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: patients from existing registries or cohorts

Condition

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

Intervention

• 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

Study Groups/Cohorts

• Register of haematological malignancies
  Interventions:

  • Other: life questionnaires
  • Other: questionnaire
• Idiopathic Pulmonary Fibrosis and PAH Cohort
  Interventions:

  • Other: life questionnaires
  • Other: questionnaire
• Giant Cell Arteritis Cohort
  Interventions:

  • Other: life questionnaires
  • Other: questionnaire
• AMD and Macular Edema Cohort
  Interventions:

  • Other: life questionnaires
  • Other: questionnaire
• Multiple Sclerosis Cohort
  Interventions:

  • Other: life questionnaires
  • Other: questionnaire
• Myocardial Infarction Observatory RICO
  Interventions:

  • Other: life questionnaires
  • Other: questionnaire
• Heart Failure Cohort
  Interventions:

  • Other: life questionnaires
  • Other: questionnaire
• Hemophilia Cohort
  Interventions:

  • Other: life questionnaires
  • Other: questionnaire

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 14, 2020): 1200
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: November 7, 2021
• Estimated Primary Completion Date: May 7, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 9 Months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04390126
• Other Study ID Numbers: BOULIN AOIc 2020
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Responsible Party: Centre Hospitalier Universitaire Dijon
• Study Sponsor: Centre Hospitalier Universitaire Dijon
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Centre Hospitalier Universitaire Dijon
• Verification Date: May 2020