A Phone-call With a Student/General Practitioner Team to Impact Morbidity of Chronic Patients During COVID-19 Containment (COVIQuest)
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ClinicalTrials.gov Identifier: NCT04359875 |
Recruitment Status :
Completed
First Posted : April 24, 2020
Last Update Posted : April 12, 2021
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Following the announcement of the containment of the population due to the COVID-19 epidemic on March 17, 2020 in France, a notable decrease in the number of consultations in general practice was reported. Patients no longer contact their general practitioner, including those with regular follow-up for one or more chronic conditions. This observation raised worries since it could lead to delay or failure in detecting decompensations / complications of these chronic conditions by a lack of recourse to care. Thus, an urgent message from the National Health Department (Direction Générale de la Santé - DGS) was adressed on April 8, 2020 to the health professionals regarding the organization of care aside from COVID-19. The main recommendation was "that the personal physician or the corresponding specialist should contact the most fragile patients with chronic condition to ensure follow-up and detect any risk of decompensation ".
Such fragile patients are in great numbers, up to more than 200 for an average general practitioner. Therefore, although this recommendation is regarded as "essential in view of the health needs of the population", it will prove quite difficult to follow without the help of a skilled external assistance that can be quickly mobilized.
Condition or disease | Intervention/treatment | Phase |
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Cardiovascular Diseases Mental Disorder | Behavioral: Phone-call screening and management by a medical student/general practitioner tandem | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Cluster randomized trial with 2 subtrials : COVIQuest_CV and COVIQuest_MH. COVIQuest_CV involves patients ≥ 70 years old suffering from chronic cardiovascular disease; and COVIQuest_MH involves patients suffering from a mental health disease. As a note, both sub-trials are two-parallel group cluster randomized trials. Clusters will be defined as practices. Practices will be randomized into two groups A and B. For practices in group A: their CV patients constitute the experimental group for the COVIQuest_CV trial, their MH patients constitute the control group for the COVIQuest_MH trial. For practices in group B: their CV patients constitute the control group for the COVIQuest_CV trial, their MH patients constitute the experimental group for the COVIQuest_MH trial. |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Does a Systematic Phone-call by a Medical Student/General Practitioner Team in Patients Suffering From a Chronic Condition During the COVID-19 Containment Period Impact One-month Hospitalization's Rate in France? A Cluster Randomized Trial |
Actual Study Start Date : | April 30, 2020 |
Actual Primary Completion Date : | June 30, 2020 |
Actual Study Completion Date : | December 31, 2020 |

Arm | Intervention/treatment |
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Experimental: Management by a student/general practitioner tandem
Patients will receive a phone call from the medical student who will inquire about their health. The medical student will then transmit this information to the general practitioner who will decide on the most suitable management for the patient.
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Behavioral: Phone-call screening and management by a medical student/general practitioner tandem
Systematic phone contact of the patient by a medical student, under the indirect supervision of the general practitioner. This phone contact will be standardized with 3 questions to ask to the patient:
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No Intervention: Usual care
Usual care, i.e. patients will call their general practitioner when needed, up to 1 month, which corresponds to the estimated time for the intervention to be delivered to all patients in the intervention group. At the end of the intervention at 1 month, patients in the usual care group will also receive a phone-call from the medical student/general practitioner tandem. |
- Hospitalization(s) at 1 month [ Time Frame: 1 month ]Hospitalization over a one month period. The primary outcome will be collected by a phone call from a medical student to the patient 1 month after randomization date. Hospitalizations (date, location, length, if available, and reason) will be collected. Because there will be many patients to be called for each practitioner, we expect these phone call to occur within a few days after day 28.
- Phone-call from the general practitioner (in the experimental group only) [ Time Frame: 1 month ]In the experimental group only: proportion of patients for whom the practitioner had to call back after the medical student had phoned (just after allocation of the practice to the experimental group) at 1 month.
- Mortality at 1 month [ Time Frame: 1 month ]Mortality will be reported after checking with the city of the patient's home if there is no response to the phone call
- Use of primary care [ Time Frame: 6 months ]Number of general practitioner consultations and teleconsultations (and time of general practitioner consultation, i.e. during the containment period or not) using data from the French Health National (SNDS) Database
- Use of secondary care [ Time Frame: 6 months ]Number of consultations with another medical specialist (and time of consultation, i.e. during the containment period or not) using data from the French Health National (SNDS) Database
- Number of prescriptions related to the chronic disease dispensed by the pharmacy [ Time Frame: 6 months ]Number of prescriptions related to the chronic disease that were dispensed by the pharmacy using data from the French Health National (SNDS) Database
- Number of hospitalization(s) [ Time Frame: 6 months ]Number of hospitalizations using data from the French Health National (SNDS) Database
- Time to hospitalization(s) [ Time Frame: 6 months ]Time to hospitalization using data from the French Health National (SNDS) Database
- Hospitalization(s)' durations [ Time Frame: 6 months ]Hospitalization duration using data from the French Health National (SNDS) Database
- Reasons for hospitalization(s) [ Time Frame: 6 months ]Reason for hospitalization using data from the French Health National (SNDS) Database
- Mortality at 6 months [ Time Frame: 6 months ]Number of deaths using data from the French Health National (SNDS) Database
- Cardiovascular events (MACE) [ Time Frame: 6 months ]Only for patients in the COVIQuest_CV sub-trial: Cardiovascular events (MACE): nonfatal stroke, nonfatal myocardial infarction, cardiovascular death and hospitalization for heart failure using data from the French Health National (SNDS) Database
- Psychotropic drugs [ Time Frame: 6 months ]Only for patients in the COVIQuest_MH sub-trial: Psychotropic drugs consumption using data from the French Health National (SNDS) Database

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Ages Eligible for Study: | 18 Years to 110 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria (patient with a chronic cardiovascular) :
- Male or female
- >= 70 years of age
- Participants covered by or entitled to social security
- With a chronic cardiovascular or mental disease as referenced in the long term illness (ALD) list (i.e. with an ALD n°1, 3, 5, 12, 13 for cardiovascular disease)
- Followed regularly by their general practitioner (i.e. entered in the list of patients followed by a general practitioner by French Health Insurance
- Participants who has given oral, express and informed consent.
Inclusion criteria (patient with a mental disease) :
- Male or female
- >= 18 years of age
- Participants covered by or entitled to social security
- With a chronic cardiovascular or mental disease as referenced in the long term illness (ALD) list (i.e. with an ALD 23 for mental disease)
- Followed regularly by their general practitioner (i.e. entered in the list of patients followed by a general practitioner by French Health Insurance
- Participants who has given oral, express and informed consent
Exclusion criteria :
- Patients with both a cardiovascular ALD and a mental health ALD (they will benefit from the intervention, without participating in the trial)
- Patients already and directly managed by their general practitioner during containment and whose general practitioner refuses that the patient be contacted by someone other than himself
- Patients unable to provide informed consent.

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): NCT04359875
France | |
Dibao-Dina | |
Tours, France, 37000 |
Study Director: | CLARISSE DIBAO-DINA, MD-PhD | University Hospital of TOURS |
Responsible Party: | University Hospital, Tours |
ClinicalTrials.gov Identifier: | NCT04359875 |
Other Study ID Numbers: |
2020-CD-COVIQuest (COVID-19) 2020-A01061-38 ( Registry Identifier: ID-RCB ) |
First Posted: | April 24, 2020 Key Record Dates |
Last Update Posted: | April 12, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | One-month-data can be shared, whereas 6-month data are not legally sharable (electronic health records). |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | 1 year |
Access Criteria: |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
general practice COVID-19 chronic diseases medical student |
COVID-19 Cardiovascular Diseases Mental Disorders Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia |
Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |