Blood Pressure Monitoring, AmbulatoryTRACANCT07740434
Work-Related Frustration and Higher Cardiovascular Risk Blood Pressure Profiles
An observational study of Blood Pressure Monitoring, Ambulatory and Cardiovascular (CV) Risk, run by University of Burgundy at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure Monitoring, Ambulatory, Cardiovascular (CV) Risk, Quality of Life at Work
- How many people
- 316 participants
- Where
- 3 sitesFrance
- Study dates
- 22 May 2023to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care working patients in primary cardiovascular prevention
Who may be able to join
- Patients aged 40 to 65 years
- Consulting one of the participating general practitioners,
- Actively working
- Without cardiovascular history or antihypertensive treatment
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Maison Universitaire de Santé et de Soins Primaires
Chenôve, 21300
Claire ZABAWA, Dr, +33380525206, clairezabawa@orange.fr
- Recruiting
Cabinet médical
Chevigny-Saint-Sauveur, 21800
Claire ZABAWA, Dr, +33380393491, clairezabawa@orange.fr
- Recruiting
Maison de Santé Pluriprofessionnelle
Pouilly-en-Auxois, 21320
Claire ZABAWA, Dr, +33380393491, clairezabawa@orange.fr
About this study
Official 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.
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.
Read more
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.
- Conditions
- Blood Pressure Monitoring, Ambulatory, Cardiovascular (CV) Risk, Quality of Life at Work, Hypertension, Frustration
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 24-hour ambulatory blood pressure monitoring recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start22 May 2023
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure Monitoring, AmbulatoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Burgundy
- Sponsor type
- University, hospital or other
- Collaborators
- Pôle Fédératif de Recherche et de Formation en Santé Publique Bourgogne-Franche-Comté, Laboratoire Psy-DREPI (UR 7458) - Université Bourgogne Europe, Département de Médecine Générale de Dijon (DMG) - Université Bourgogne Europe
- Responsible party
- Principal investigator, Dr Claire ZABAWA, University of Burgundy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740434
- Sponsor's protocol ID
- 2022-A02249-34
- Acronym
- TRACA
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07740434
- Acronym / sponsor ID
- TRACA / 2022-A02249-34
- Conditions
- Blood Pressure Monitoring, Ambulatory, Cardiovascular (CV) Risk, Quality of Life at Work, Hypertension, Frustration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- University of BurgundyUniversity, hospital or other
- Collaborators
- Pôle Fédératif de Recherche et de Formation en Santé Publique Bourgogne-Franche-Comté, Laboratoire Psy-DREPI (UR 7458) - Université Bourgogne Europe, Département de Médecine Générale de Dijon (DMG) - Université Bourgogne Europe
- Study start
- 22 May 2023 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care working patients in primary cardiovascular prevention
Key inclusion criteria (4 listed)
- Patients aged 40 to 65 years
- Consulting one of the participating general practitioners,
- Actively working
- Without cardiovascular history or antihypertensive treatment
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure Monitoring, Ambulatory and Cardiovascular (CV) Risk, run by University of Burgundy at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire ZABAWA, Dr (+33699835326, claire.zabawa@u-bourgogne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of masked hypertension (time frame: 24-hour ambulatory blood pressure monitoring recording). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.