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NCT Number: NCT07740434

Work-Related Frustration and Higher Cardiovascular Risk Blood Pressure Profiles

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maison Universitaire de Santé et de Soins Primaires, Chenôve, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Prevalence of masked hypertension

    Time frame: 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)

  2. Prevalence of white-coat hypertension

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Claire ZABAWA, Dr

CONTACT

[email protected]

+33699835326

Sponsors and collaborators

Lead sponsor

University of Burgundy

Other

Collaborators

  • Département de Médecine Générale de Dijon (DMG) - Université Bourgogne Europe
  • Laboratoire Psy-DREPI (UR 7458) - Université Bourgogne Europe
  • Pôle Fédératif de Recherche et de Formation en Santé Publique Bourgogne-Franche-Comté

Registry information

Official study title

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.

Acronym: TRACA

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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