Prospective, Multicenter Study Assessing a Screening Campaign for Cardiovascular Diseases Risk Factors During SARS-CoV-2 Epidemic

NCT05293379 | Completed

• 1 other identifier: VACCIPREV
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Health Behavior; Cardiovascular Diseases; Cardiovascular Morbidity

Keywords

cardiovascular risk factors; public health; screening campaign; cardiovascular disease; prevention; medical management

Outcome Measures

Primary Outcomes (1)

• Rate of patients with pathological constants and have initiated a medical management

  Number of patients with pathological vitals and have initiated a medical management by a primary care physician or a specialist and whose constants'pathological criteria is confirmed by a physician

  An average of 3 months

Secondary Outcomes (3)

• Impact of the screening campaign in the population without a primary care physician

  An average of 3 months

• Cardiovascular risk factors in the population without a primary care physician

  An average of 3 months

• Impact of the VACCIPREV program in strengthening the relationship between the community medecine and the coordination of healthcare circuits.

  An average of 3 months

Study Arms (1)

Patients sensitized in the VACCIPREV program

Patients from 3 vaccination centers who agreed to participate to the VACCIPREV program by using the teleconsultation booth and completing the questionnaires of tobacco dependance and assessment of sleep quality.

Other: Connected teleconsultation booth

Interventions

Connected teleconsultation booth OTHER

15-minutes assessment in a connected teleconsultation booth.

Patients sensitized in the VACCIPREV program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The targeting of patients covered the period from July 2021 to September 2021 corresponding to the period where the booth were available in vaccination centers. Data's extraction 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 management. More than 6,000 people were sensitized within the framework of the VACCIPREV program, among them, about 2,400 patients have agreed to benefit from the independent assessment via the CONSULT STATION® within this same program in 3 months on the 3 sites. About 750 patients had a result with pathological constants and were invited to consult their attending physician.

You may qualify if:

• Patients informed of the study (information sheet given to patients) and who had not given their opposition to the collection of data for research purposes
• Woman or man aged 18 or over
• Patients registered with a social security scheme

You may not qualify if:

• Patients unable to understand the directives requested for the use of the cabin
• Patients under legal protection
• Patients who have expressed their opposition to the use of their data

Sponsors & Collaborators

• Elsan: lead

Study Sites (4)

Clinique de Saint Omer

Blendecques, 62575, France

Location

Hôpital Privé Saint Claude

Saint-Quentin, 02100, France

Location

Clinique Vauban

Valenciennes, 59300, France

Location

Hôpital privé du Hainaut

Valenciennes, 59300, France

Location

MeSH Terms

Conditions

Health Behavior; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 24, 2022
• Study Start: July 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: July 1, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)