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

2022年12月5日 更新者:Elsan

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

調査の概要

詳細な説明

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)

研究の種類

観察的

入学 (実際)

2400

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Blendecques、フランス、62575
        • Clinique de Saint Omer
      • Saint Quentin、フランス、02100
        • Hôpital privé Saint Claude
      • Valenciennes、フランス、59300
        • Clinique Vauban
      • Valenciennes、フランス、59300
        • Hôpital privé du Hainaut

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:コホート
  • 時間の展望:回顧

コホートと介入

グループ/コホート
介入・治療
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.
15-minutes assessment in a connected teleconsultation booth.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Rate of patients with pathological constants and have initiated a medical management
時間枠:An average of 3 months
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

二次結果の測定

結果測定
メジャーの説明
時間枠
Impact of the screening campaign in the population without a primary care physician
時間枠:An average of 3 months
Number of patients without a primary care physician with pathological findings and have initiated medical management by a general physician or a specialist and whose constant's pathological criteria is confirmed by the physician
An average of 3 months
Cardiovascular risk factors in the population without a primary care physician
時間枠:An average of 3 months
Comparison of cardiovascular disease risk factors in patients monitored by a primary care physician with patients who are not monitored by 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.
時間枠:An average of 3 months
The reinforcement of patients' reffering to community medecine will be evaluated with NECTAR software (establishment of the connection with community medicine)
An average of 3 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年7月1日

一次修了 (実際)

2021年9月1日

研究の完了 (実際)

2022年7月1日

試験登録日

最初に提出

2022年3月11日

QC基準を満たした最初の提出物

2022年3月21日

最初の投稿 (実際)

2022年3月24日

学習記録の更新

投稿された最後の更新 (見積もり)

2022年12月7日

QC基準を満たした最後の更新が送信されました

2022年12月5日

最終確認日

2022年12月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • VACCIPREV

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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