High Blood PressureNCT05814068
Active Screening of Arterial Hypertension by Community Outreach Workers in the Cayenne Metropolitan Area to Reduce the Incidence of Cardiovascular Disease
A study testing antihypertensive drug treatment in people with High Blood Pressure, run by Centre Hospitalier de Cayenne.
Trial summary
The main objective is to implement of a community-based primary care intervention against high blood pressure. We want to show that this intervention decreases the incidence of stroke in the community of agglomerations of the central coast of French Guiana, with a rapid effectiveness of about -30% at 2 years. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- antihypertensive drug treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults of at least 18 years old
- Residents of the agglomeration community of the central coast of French Guiana.
Who cannot join
- Person who has objected to participating in the study
- Person under guardianship or curatorship, persons under protective supervision
Trial locations and contacts
No sites are listed yet.
About this study
The main objective is to implement of a community-based primary care intervention against high blood pressure. We want to show that this intervention decreases the incidence of stroke in the community of agglomerations of the central coast of French Guiana, with a rapid effectiveness of about -30% at 2 years.
Read the detailed description
The hypothesis of the research is that, thanks to a strategy of early detection of hypertension based on "outreach" by community relays, it will be possible to increase the effectiveness of primary prevention among the precarious population (early treatment, access to healthcare, improvement of therapeutic follow-up, reduction of renunciations and interruptions of treatment). This strategy, adapted to the Guianese context, would make it possible to reduce the incidence and mortality of cardiovascular diseases among the most vulnerable people, particularly stroke. Such data would be a prerequisite for a more ambitious strategy, aiming to implement policies on a sufficient scale policies on a scale and intensity sufficient to have an impact on the problem of social inequalities in health other than those related to high blood pressure.
The quasi-experimental before-and-after methodology makes it possible to compare, on a population basis, a quantitative endpoint - in this case the number of strokes - between before and after the implementation of a public health intervention. For reasons of acceptance by the partners, statistical power, and potential bias, a before-and-after design seems more interesting.
It will be a pre-screening of hypertension, a possible referral for medical care or opening of health care rights and health education through hygienic and dietary advice and health prevention focused on hypertension.
- Conditions
- High Blood Pressure
- Being tested
- antihypertensive drug treatment
- Keywords
- High blood pressure, Precarity, community outreach workers, Cardiovascular disease, Health care
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antihypertensive drug treatmentDrug
Patients with hypertension will be treated for it by their physician
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | diagnosis and treatment of high blood pressure Receives: Drug: antihypertensive drug treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the incidence of stroke between before and after the start of the intervention according to PMSI data in resident persons in the agglomeration community of the central coast of French Guiana.
To compare the incidence of stroke between before and after the intervention
Measured: 5 years
Secondary outcomes (6)
The incidence of acute coronary syndrome (ACS), transient ischemic attack, lower extremity arterial disease, aneurysm and end stage renal disease treated.
Measured: comparison between before (over 5 years) and 1, 2 and 3 years after the beginning of the intervention according to PMSI data in the neighborhoods
Stroke incidence
Measured: comparison between before (over 5 years) and 1, 2 and 3 years after the beginning of the intervention according to PMSI data in the neighborhoods
treatment adherence
lickert scale (5 levels)
Measured: Inclusion
Number of systolic and diastolic blood pressure measurements performed, number of new diagnoses and number of rediscoveries among those lost to follow-up during the intervention (number of people who give up on diagnosis or medical care)
Measured: 2 years
Quantification of the evolution of the prescription of antihypertensive drugs in Guiana via data from the Social Security
Measured: Before and 1, 2, and 3 years after the implementation of the intervention
stroke in hospital case fatality
Measured: 1, 2, and 3 years after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for High Blood PressureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu NACHER, PhD, Principal investigator, Centre Hospitalier de Cayenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814068
- Sponsor's protocol ID
- DEPIPREC
- Status last verified
- Feb 2023
- First submitted
- 3 Mar 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mackenbach JP. Can we reduce health inequalities? An analysis of the English strategy (1997-2010). J Epidemiol Community Health. 2011 Jul;65(7):568-75. doi: 10.1136/jech.2010.128280. Epub 2011 Apr 1.
PubMed 21459930Mackenbach JP. Has the English strategy to reduce health inequalities failed? Soc Sci Med. 2010 Oct;71(7):1249-1253. doi: 10.1016/j.socscimed.2010.07.014. Epub 2010 Aug 3. No abstract available.
PubMed 20736133NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021 Sep 11;398(10304):957-980. doi: 10.1016/S0140-6736(21)01330-1. Epub 2021 Aug 24.
PubMed 34450083Rochemont DR, Mimeau E, Misslin-Tritsch C, Papaix-Puech M, Delmas E, Bejot Y, DeToffol B, Fournel I, Nacher M. The epidemiology and management of stroke in French Guiana. BMC Neurol. 2020 Mar 24;20(1):109. doi: 10.1186/s12883-020-01650-2.
PubMed 32209060Rochemont DR, Lemenager P, Franck Y, Farhasmane A, Sabbah N, Nacher M. The epidemiology of acute coronary syndromes in French Guiana. Ann Cardiol Angeiol (Paris). 2021 Feb;70(1):7-12. doi: 10.1016/j.ancard.2020.09.032. Epub 2020 Oct 14.
PubMed 33067006Valmy L, Gontier B, Parriault MC, Van Melle A, Pavlovsky T, Basurko C, Grenier C, Douine M, Adenis A, Nacher M. Prevalence and predictive factors for renouncing medical care in poor populations of Cayenne, French Guiana. BMC Health Serv Res. 2016 Jan 28;16:34. doi: 10.1186/s12913-016-1284-y.
PubMed 26822003Van Melle A, Cropet C, Parriault MC, Adriouch L, Lamaison H, Sasson F, Duplan H, Richard JB, Nacher M. Renouncing care in French Guiana: the national health barometer survey. BMC Health Serv Res. 2019 Feb 6;19(1):99. doi: 10.1186/s12913-019-3895-6.
PubMed 30728033Hart JT. Commentary: Can health outputs of routine practice approach those of clinical trials? Int J Epidemiol. 2001 Dec;30(6):1263-7. doi: 10.1093/ije/30.6.1263. No abstract available.
PubMed 11821324Addo J, Ayerbe L, Mohan KM, Crichton S, Sheldenkar A, Chen R, Wolfe CD, McKevitt C. Socioeconomic status and stroke: an updated review. Stroke. 2012 Apr;43(4):1186-91. doi: 10.1161/STROKEAHA.111.639732. Epub 2012 Feb 23.
PubMed 22363052Rochemont DR, Mergeay-Fabre M, Fahrasmane A, Boceno C, Nacher M. Community-Based Hypertension Screening to Prevent Stroke in Underserved Urban Neighborhoods in French Guiana: Protocol for a Quasi-Experimental Study. JMIR Res Protoc. 2026 Aug 27;15:e89318. doi: 10.2196/89318.
PubMed 42659643
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Screening of Arterial Hypertension by Community Outreach Workers in the Cayenne Metropolitan Area to Reduce the Incidence of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT05814068
- Acronym / sponsor ID
- DEPIPREC
- Conditions
- High Blood Pressure
- Keywords
- High blood pressure, Precarity, community outreach workers, Cardiovascular disease, Health care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 14 Apr 2023 (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.
The main objective is to implement of a community-based primary care intervention against high blood pressure. We want to show that this intervention decreases the incidence of stroke in the community of agglomerations of the central coast of French Guiana, with a rapid effectiveness of about -30% at 2 years.
Detailed description
The hypothesis of the research is that, thanks to a strategy of early detection of hypertension based on "outreach" by community relays, it will be possible to increase the effectiveness of primary prevention among the precarious population (early treatment, access to healthcare, improvement of therapeutic follow-up, reduction of renunciations and interruptions of treatment). This strategy, adapted to the Guianese context, would make it possible to reduce the incidence and mortality of cardiovascular diseases among the most vulnerable people, particularly stroke. Such data would be a prerequisite for a more ambitious strategy, aiming to implement policies on a sufficient scale policies on a scale and intensity sufficient to have an impact on the problem of social inequalities in health other than those related to high blood pressure.
The quasi-experimental before-and-after methodology makes it possible to compare, on a population basis, a quantitative endpoint - in this case the number of strokes - between before and after the implementation of a public health intervention. For reasons of acceptance by the partners, statistical power, and potential bias, a before-and-after design seems more interesting.
It will be a pre-screening of hypertension, a possible referral for medical care or opening of health care rights and health education through hygienic and dietary advice and health prevention focused on hypertension.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: antihypertensive drug treatmentdiagnosis and treatment of high blood pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults of at least 18 years old
- Residents of the agglomeration community of the central coast of French Guiana.
Key exclusion criteria (2 listed)
- Person who has objected to participating in the study
- Person under guardianship or curatorship, persons under protective supervision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antihypertensive drug treatmentPatients with hypertension will be treated for it by their physician | Drug | Intervention |
Primary outcome
To compare the incidence of stroke between before and after the start of the intervention according to PMSI data in resident persons in the agglomeration community of the central coast of French Guiana.
Time frame: 5 years
To compare the incidence of stroke between before and after the intervention
6 secondary outcomes
The incidence of acute coronary syndrome (ACS), transient ischemic attack, lower extremity arterial disease, aneurysm and end stage renal disease treated.
Time frame: comparison between before (over 5 years) and 1, 2 and 3 years after the beginning of the intervention according to PMSI data in the neighborhoods
Stroke incidence
Time frame: comparison between before (over 5 years) and 1, 2 and 3 years after the beginning of the intervention according to PMSI data in the neighborhoods
treatment adherence
Time frame: Inclusion
Number of systolic and diastolic blood pressure measurements performed, number of new diagnoses and number of rediscoveries among those lost to follow-up during the intervention (number of people who give up on diagnosis or medical care)
Time frame: 2 years
Quantification of the evolution of the prescription of antihypertensive drugs in Guiana via data from the Social Security
Time frame: Before and 1, 2, and 3 years after the implementation of the intervention
stroke in hospital case fatality
Time frame: 1, 2, and 3 years after the start of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Background: PubMed 21459930Mackenbach JP. Can we reduce health inequalities? An analysis of the English strategy (1997-2010). J Epidemiol Community Health. 2011 Jul;65(7):568-75. doi: 10.1136/jech.2010.128280. Epub 2011 Apr 1.
- Background: PubMed 20736133Mackenbach JP. Has the English strategy to reduce health inequalities failed? Soc Sci Med. 2010 Oct;71(7):1249-1253. doi: 10.1016/j.socscimed.2010.07.014. Epub 2010 Aug 3. No abstract available.
- Background: PubMed 34450083NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021 Sep 11;398(10304):957-980. doi: 10.1016/S0140-6736(21)01330-1. Epub 2021 Aug 24.
- Background: PubMed 32209060Rochemont DR, Mimeau E, Misslin-Tritsch C, Papaix-Puech M, Delmas E, Bejot Y, DeToffol B, Fournel I, Nacher M. The epidemiology and management of stroke in French Guiana. BMC Neurol. 2020 Mar 24;20(1):109. doi: 10.1186/s12883-020-01650-2.
- Background: PubMed 33067006Rochemont DR, Lemenager P, Franck Y, Farhasmane A, Sabbah N, Nacher M. The epidemiology of acute coronary syndromes in French Guiana. Ann Cardiol Angeiol (Paris). 2021 Feb;70(1):7-12. doi: 10.1016/j.ancard.2020.09.032. Epub 2020 Oct 14.
- Background: PubMed 26822003Valmy L, Gontier B, Parriault MC, Van Melle A, Pavlovsky T, Basurko C, Grenier C, Douine M, Adenis A, Nacher M. Prevalence and predictive factors for renouncing medical care in poor populations of Cayenne, French Guiana. BMC Health Serv Res. 2016 Jan 28;16:34. doi: 10.1186/s12913-016-1284-y.
- Background: PubMed 30728033Van Melle A, Cropet C, Parriault MC, Adriouch L, Lamaison H, Sasson F, Duplan H, Richard JB, Nacher M. Renouncing care in French Guiana: the national health barometer survey. BMC Health Serv Res. 2019 Feb 6;19(1):99. doi: 10.1186/s12913-019-3895-6.
- Background: PubMed 11821324Hart JT. Commentary: Can health outputs of routine practice approach those of clinical trials? Int J Epidemiol. 2001 Dec;30(6):1263-7. doi: 10.1093/ije/30.6.1263. No abstract available.
- Background: PubMed 22363052Addo J, Ayerbe L, Mohan KM, Crichton S, Sheldenkar A, Chen R, Wolfe CD, McKevitt C. Socioeconomic status and stroke: an updated review. Stroke. 2012 Apr;43(4):1186-91. doi: 10.1161/STROKEAHA.111.639732. Epub 2012 Feb 23.
- Derived from this study: PubMed 42659643Rochemont DR, Mergeay-Fabre M, Fahrasmane A, Boceno C, Nacher M. Community-Based Hypertension Screening to Prevent Stroke in Underserved Urban Neighborhoods in French Guiana: Protocol for a Quasi-Experimental Study. JMIR Res Protoc. 2026 Aug 27;15:e89318. doi: 10.2196/89318.
- Article - Bulletin épidémiologique hebdomadaire n.dLink provided by the sponsor.
- Rochemont DR, Dueymes JM, Roura R, Meddeb M, Couchoud C, Nacher M. End stage renal disease as a symptom of health inequalities in French Guiana.Link provided by the sponsor.
- 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. This study is not recruiting at the moment.
Mathieu NACHER, PhD principal investigator
Centre Hospitalier de Cayenne
Questions about this trial
What is this clinical trial studying?
A study testing antihypertensive drug treatment in people with High Blood Pressure, run by Centre Hospitalier de Cayenne.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathieu NACHER, PhD (+594594395385, mathieu.nacher@ch-cayenne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the incidence of stroke between before and after the start of the intervention according to PMSI data in resident persons in the agglomeration community of the central coast of French Guiana. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05814068, which also lists 10 linked publications.
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 14 Apr 2023.