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临床试验/NCT07740434
NCT07740434招募中不适用

Work-Related Frustration and Higher Cardiovascular Risk Blood Pressure Profiles: A Regional Proof-of-Concept Study on Work-Related Quality of Life and Cardiovascular Prevention.

University of Burgundy3 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2023年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
316
试验地点
3
主要终点
Prevalence of masked hypertension

研究概览

简要总结

Background: Mental health is a national priority in France, especially in the workplace. The impact of poor quality of life at work on mental health has been demonstrated. Raising awareness of the importance of prevention within companies and the influence of working conditions seems essential. In the context of limited occupational health physicians, inherent access difficulties, and reduced resources, physical health is often addressed as the first line of intervention. In the Burgundy region, the prevention of cardiovascular diseases is a regional public health concern. A significant association has been found between effort/reward imbalance and masked hypertension. Identifying a link between working conditions, blood pressure profile, and thus increased cardiovascular risk would be relevant.

Objectives: The main goal of this observational study is to compare the frequency of blood pressure profiles at higher risk of cardiovascular events (white coat hypertension and daytime and/or nighttime masked hypertension) according to work-related quality of life and perceived stress levels among primary care patients without a history of hypertension or cardiovascular disease, in two departments of the Burgundy region.

Methods: This project is a proof-of-concept study before intervention on work-related quality of life and blood pressure profiles at higher cardiovascular risk in primary prevention. It is a prospective, interventional, and multicenter study, conducted from May 2023, across three multidisciplinary primary care centers, involving fifteen general practitioners from Côte d'Or and Saône-et-Loire. Patients aged 40 to 65, consulting one of the participating general practitioners, actively working, with no cardiovascular history or antihypertensive treatment, will be included. Work-related quality of life and perceived stress will be assessed using the QualTra-Scale and the PSS-10 scale, respectively. All included patients will undergo 24-hour ambulatory blood pressure monitoring (ABPM) during a workday. A qualitative component will complement the results through patients' individual interviews exploring ABPM perception and reasons for refusal, and focus groups involving general practitioners and occupational health professionals to explore perceptions and potential intervention strategies.

Perspectives: The main perspective of this study is to focus on workplace health by providing additional data on the physical repercussions of poor work-related quality of life and high perceived stress. Objectifying a confirmed medical situation could serve as a lever for identifying mental health issues. It would enable interventions to improve work-related quality of life by addressing health determinants and psychosocial risks. Various interventions could be considered through a multidisciplinary approach in the workplace, involving occupational physicians, occupational psychologists, and employers. This study could also offer insights into patient profiles at higher cardiovascular risk, help develop recommendations for screening masked hypertension, and evaluate the role of blood pressure measurements at the workplace.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 40 to 65 years
  • Consulting one of the participating general practitioners,
  • Actively working
  • Without cardiovascular history or antihypertensive treatment

排除标准

  • 未提供

结局指标

主要结局

Prevalence of masked hypertension

时间窗: 24-hour ambulatory blood pressure monitoring recording

Normal office blood pressure (BP \<140/90 mmHg) AND 24-hour ambulatory blood pressure hypertension (daytime BP ≥135/85 mmHg OR nighttime BP ≥120/70 mmHg)

Prevalence of white-coat hypertension

时间窗: 24-hour ambulatory blood pressure monitoring recording

High office blood pressure (BP ≥140/90 mmHg) AND normal 24-hour ambulatory blood pressure (daytime BP \<135/85 mmHg AND nighttime BP \<120/70 mmHg)

次要结局

未报告次要终点

研究者

发起方
University of Burgundy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Claire ZABAWA

General Practitioner - University Lecturer

University of Burgundy

研究点 (3)

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