Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05293379 |
| Other study ID # |
VACCIPREV |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2021 |
| Est. completion date |
July 1, 2022 |
Study information
| Verified date |
December 2022 |
| Source |
Elsan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The goal of this prospective study is to evaluate the impact of an innovative screening
campagn (using the medical device "CONSULT STATION®" on french population healthcare . The
main aims of this study are:
- To determine whether a screening campaign for cardiovascular disease risk factor has a
greater impact on the population who is not monitored by a primary care physician
- To determine whether people who are not monitored by a primary care physician have
greater cardiovascular risk
- To determine whether the screening campaign offered to the general population has
strengthened the relationship between community medecine and healthcare circuit
coordination
Data of patients from vaccination center who agreed to participate to the screening campaign
by using the medical device "CONSULT STATION®" will be analyzed.
Patients will also be called at least 3 months after their visit in the vaccination center in
order to assess the impact of the screening campaign on their medical monitoring
Description:
Cardiovascular diseases and its complications are the leading cause of death in the world. In
France, they are the second leading cause of death after cancer, with over 140,000 deaths
each year.
The number of people with cardiovascular disease increases with the aging of the population,
and strong social and territorial inequalities persist. Innovative cardiovascular risk
factors screening campaign can have significant public interest, especially to raise
awareness and diagnose a particular population which is not monitored by a physician on a
regular basis.
The VACCIPREV project emerged during the Covid-19 pandemic. The founding idea was to use the
time people spent in vaccination centers to raise awareness and to diagnose people, for some,
never go to a health facility. Indeed, a portion of the population free of all medical
conditions, of all ages, including young people without known comorbidities, then crossed the
threshold of our institutions to get vaccinated.
VACCIPREV is part of a global territorial prevention will to propose to this population flow
an innovative medical technology optimizing all stages of vaccination.
In association with a French company named "H4D", developing a connected teleconsultation
booth (CONSULT STATION®), an independent health check was thus structured, in addition with
two questionnaires given during the waiting phase before vaccination: one concerning tobacco
dependance and the other assessing the sleep quality. This health check focuses on the early
detection of cardiovascular risk factors. It is indeed a key issue for medical management and
VACCIPREV allows to respond to this issue in an innovative and playful way.
The CONSULT STATION® (Class IIa medical device certified according to European Directive
93/42/EEC) offers 15-minutes assessment of blood pressure, heart rate, oxygen saturation,
BMI, but also the performance of visual tests. Accompanied by a caregiver in the process, the
person gets in real time these different medical constants and thanks to a simple and
graduated evaluation scale, a review of his results and a recommendation to visit his doctor
if necessary. In case of potentially pathological results, and with the person's consent,
contact informations (telephone/email) were collected to remotely assess the impact of this
screening campaign.
VACCIPREV programme included an idependant medical check-up with the connected booth H4D,
questionnaires of tabacco dependance and assessment of sleep quality and a remote assessment
of their impact on the medical management of people with pathological constants. A telephone
interview was carried out after a period of at least 3 months following the passage in the
cabin to complete the medical questionnaire in order to evaluate changes in patients medical
management. This included assessing the impact of the approach.
It was an observational study on data from an historic and prospective cohorte, multicentered
national and not randomized. The study period was between 1st july 2021 and 1st july 2022.
The main objective of the study was to determine whether the innovative screening campaign
has impacted the health management of the population.
Secondary objectives were:
- To determine whether the screening campaign's impact was greater in the population who
is not monitored by a primary care physician
- To determine whether people who are not monitored by a physician have greater
cardiovascular risk
- To determine whether the screening campaign offered to the general population has
strengthened the relationship between community medecine and healthcare circuit
coordination The objectives will be analysed both for all centers but aslo for each
center in order to highlight a possible regional differences in the medical management
of the population. Evaluation criteria concerning the objectives covered by this
protocol will be based on a description of the data collected from the telephone
interview (consultation with a general physician, consultation with a specialist,
statement from a primary care physician)
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