VACCIPREV: COVID-19. Screening Campaign for Risk Factors Cardiovascular Diseases During the Epidemic by SARS-CoV-2

Sponsor
Elsan (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05293379
Collaborator
(none)
2,400
2
15
1200
79.9

Study Details

Study Description

Brief Summary

In France, the Covid-19 pandemic has required the implementation of exceptional health measures.

The influx of a greater number of sick people into health facilities has necessitated a restructuring of the healthcare system with mobilization of nursing staff and reorganization of care in particular by deprogramming non-essential and non-urgent care (operations, interventions and consultations whose postponement would not cause harm to patients).

To limit the spread of the virus and provide care for sick people, the government French has introduced containment measures. The Covid-19 epidemic and the various measures taken to try to curb it have led to a sharp fall consultations with general practitioners and specialists. The use of teleconsultations did not allow to stem this decline.

There are many reasons for refusing treatment: the fear of being contaminated by the coronavirus while moving in a medical office, the fear of disturbing health professionals but also the closure of certain medical offices.

One of the major risks of this renunciation of care is to postpone the diagnosis of serious illnesses whose outcome can be fatal or disabling in the long term. However, taken in time, certain pathologies can be stopped or, at least, see their progress greatly slowed down

Condition or Disease Intervention/Treatment Phase
  • Other: Non-interventionnal and observationnal

Detailed Description

The VACCIPREV project emerged in the midst of the Covid-19 pandemic period, in the deployment phase in the ELSAN establishments in Hauts de France vaccination centers for the general population.

The founding idea was to take advantage of the time spent in the vaccination center to raise awareness and diagnose people, some of whom never go to a health facility. In effect, a part of the population free from any medical pathology followed, all ages combined, and including young people without known comorbidities then crossed the threshold of our establishments to be vaccinated. VACCIPREV is part of a desire for global territorial prevention to offer this population flow screening innovative medicine optimizing all stages of vaccination.

In association with a French company, H4D, developing a connected teleconsultation cabin (CONSULT STATIONĀ®), an autonomous health check-up was thus structured, with the delivery in addition of two questionnaires on tobacco dependence and the evaluation of the quality of sleep during the waiting phase of the vaccination. This health check-up focuses on the early detection of cardiovascular risk factors.

This is indeed a key issue in medical care and VACCIPREV, through its innovative and playful, makes it possible to respond to this issue. The CONSULT STATIONĀ® (class IIa medical device certified according to European directive 93/42/EEC) offers a 15-minute assessment of blood pressure, heart rate, oxygen saturation, BMI but also the realization of visual tests. Accompanied by a carer in the process, the person obtains real time these various medical constants and thanks to a simple and graduated evaluation scale, a analysis of his results and a recommendation to go to his doctor if necessary. In case of potentially pathological results, and after consent of the person, their contact details (telephone and/or email) were collected in order to remotely assess the impact of this screening campaign.

The VACCIPREV program includes an autonomous medical check-up by the H4D connected cabin, the sleep assessment and smoking questionnaires, and the remote assessment of its impact on the medical care of people with pathological constants.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
2400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Multicenter Study Evaluating a Screening Campaign for Risk Factors Cardiovascular Diseases During the Epidemic by SARS-CoV-2. VACCIPREV
Actual Study Start Date :
Jul 1, 2021
Actual Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Patients sensitized within the framework of the VACCIPREV program

The targeting of patients covered the period from July 2021 to September 2021 corresponding to the period where the booth was available at vaccination centers. Data mining will extend from July 2021 to July 2022 in order to have a follow-up of at least 3 months after the passage in the cabin and to observe the potential modifications or initiation of patient care

Other: Non-interventionnal and observationnal
No intervention

Outcome Measures

Primary Outcome Measures

  1. Rate of patients with constants pathological and having initiated a treatment medical charge [An average of 3 months]

    Number of patients with constants pathological and having initiated treatment medical by a general practitioner or specialist and whose pathological character is confirmed by doctor

Secondary Outcome Measures

  1. Impact of the screening campaign in the population not benefiting from doctor [An average of 3 months]

    Number of patients without a doctor dealing with pathological constants and having initiated medical treatment by a doctor generalist or specialist and whose character pathological is confirmed by the doctor

  2. Cardiovascular risk factors in the population not benefiting from doctor [An average of 3 months]

    Comparison of risk factors cardiovascular disease in patients undergoing attending physician in relation to patients benefiting from no attending physician.

  3. Impact of the VACCIPREV program on strengthening the link with the medicine of city and the coordination of care pathways [An average of 3 months]

    Reinforcement of addressing with the medicine of city will be evaluated with NECTAR software (establishment of the link with city medicine)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patient having been informed of the study (information note given to patients) and not having given his opposition to the collection of data for research purposes

  • Woman or man aged 18 or over

  • Affiliation to a social security scheme

Exclusion Criteria:
  • Patients unable to understand the directives requested for the use of the cabin

  • Patients under legal protection

  • Patients who have expressed opposition to the use of their data

Contacts and Locations

Locations

Site City State Country Postal Code
1 Polyclinique Vauban Valenciennes France 59300
2 Clinique Vauban Valenciennes France

Sponsors and Collaborators

  • Elsan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elsan
ClinicalTrials.gov Identifier:
NCT05293379
Other Study ID Numbers:
  • VACCIPREV
First Posted:
Mar 24, 2022
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2022