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Not yet recruitingNCT05814068Updated Apr 14, 2023

Active Screening of Arterial Hypertension by Community Outreach Workers in the Cayenne Metropolitan Area to Reduce the Incidence of Cardiovascular Disease

An interventional study of antihypertensive drug treatment in High Blood Pressure, sponsored by Centre Hospitalier de Cayenne. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-14.

Sponsored by Centre Hospitalier de Cayenne · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50,000
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • High Blood Pressure

Keywords

  • High blood pressure
  • Precarity
  • community outreach workers
  • Cardiovascular disease
  • Health care
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 50,000 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Centre Hospitalier de Cayenne is the lead sponsor of 47 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adults of at least 18 years old
  • Residents of the agglomeration community of the central coast of French Guiana.

Exclusion criteria

Exclusion Criteria:

  • Person who has objected to participating in the study
  • Person under guardianship or curatorship, persons under protective supervision
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50,000 participants (estimated)

Study arms

  • Experimental
    Intervention

    diagnosis and treatment of high blood pressure

    Drug: antihypertensive drug treatment

Interventions

  • Drugantihypertensive drug treatment

    Patients with hypertension will be treated for it by their physician

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 5 years

Secondary outcomes

  1. 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

  2. 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

  3. treatment adherence

    lickert scale (5 levels)

    Time frame: Inclusion

  4. 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

  5. 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

  6. stroke in hospital case fatality

    Time frame: 1, 2, and 3 years after the start of the intervention

07

Study locations

No study locations are listed for this record.

08

References and documents

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 21459930 ↗
  • Mackenbach 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 20736133 ↗
  • NCD 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. Erratum In: Lancet. 2022 Feb 5;399(10324):520. doi: 10.1016/S0140-6736(22)00061-7. PubMed 34450083 ↗
  • Rochemont 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 32209060 ↗
  • Rochemont 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 33067006 ↗
  • Valmy 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 26822003 ↗
  • Van 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 30728033 ↗
  • Hart 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 11821324 ↗
  • Addo 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 22363052 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05814068
Lead sponsor
Centre Hospitalier de Cayenne
Responsible party
Sponsor
First posted
Apr 14, 2023
Start date
May 1, 2023 (estimated)
Primary completion
May 1, 2025 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
Apr 14, 2023

Study contacts

Mathieu NACHER, PhD
Contact
mathieu.nacher@ch-cayenne.fr
+594594395385
Devi ROCHEMONT, PhD
Contact
devi.rochemont@ch-cayenne.fr
+594594395385
Mathieu NACHER, PhD
principal investigator · Centre Hospitalier de Cayenne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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