이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2022년 12월 5일 업데이트: 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

연구 개요

상세 설명

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)

연구 유형

관찰

등록 (실제)

2400

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Blendecques, 프랑스, 62575
        • Clinique de Saint Omer
      • Saint Quentin, 프랑스, 02100
        • Hôpital privé Saint Claude
      • Valenciennes, 프랑스, 59300
        • Clinique Vauban
      • Valenciennes, 프랑스, 59300
        • Hôpital privé du Hainaut

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: 보병대
  • 시간 관점: 회고전

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Rate of patients with pathological constants and have initiated a medical management
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Impact of the screening campaign in the population without a primary care physician
기간: 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
기간: 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.
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 7월 1일

기본 완료 (실제)

2021년 9월 1일

연구 완료 (실제)

2022년 7월 1일

연구 등록 날짜

최초 제출

2022년 3월 11일

QC 기준을 충족하는 최초 제출

2022년 3월 21일

처음 게시됨 (실제)

2022년 3월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2022년 12월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 12월 5일

마지막으로 확인됨

2022년 12월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • VACCIPREV

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

심혈관 질환에 대한 임상 시험

Connected teleconsultation booth에 대한 임상 시험

구독하다