NCT07740434

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
May 2023May 2028

Study Start

First participant enrolled

May 22, 2023

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

4.9 years

First QC Date

July 28, 2026

Last Update Submit

July 28, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Prevalence of masked hypertension

    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)

    24-hour ambulatory blood pressure monitoring recording

  • Prevalence of white-coat hypertension

    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)

    24-hour ambulatory blood pressure monitoring recording

Study Arms (1)

Workers from 40 to 65 years, in primary cardiovascular prevention, consulting at general practice

Working patients consulting at one of the research primary care centers, aged 40 to 65 years, with no history of hypertension or cardiovascular disease, and not taking antihypertensive medication

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care working patients in primary cardiovascular prevention

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Maison Universitaire de Santé et de Soins Primaires

Chenôve, 21300, France

RECRUITING

Cabinet médical

Chevigny-Saint-Sauveur, 21800, France

RECRUITING

Maison de Santé Pluriprofessionnelle

Pouilly-en-Auxois, 21320, France

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Practitioner - University Lecturer

Study Record Dates

First Submitted

July 28, 2026

First Posted

July 31, 2026

Study Start

May 22, 2023

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

July 31, 2026

Record last verified: 2026-07

Locations