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

Primary Purpose

High Blood Pressure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
antihypertensive drug treatment
Sponsored by
Centre Hospitalier de Cayenne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for High Blood Pressure focused on measuring High blood pressure, Precarity, community outreach workers, Cardiovascular disease, Health care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adults of at least 18 years old Residents of the agglomeration community of the central coast of French Guiana. Exclusion Criteria: Person who has objected to participating in the study Person under guardianship or curatorship, persons under protective supervision

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    diagnosis and treatment of high blood pressure

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    The incidence of acute coronary syndrome (ACS), transient ischemic attack, lower extremity arterial disease, aneurysm and end stage renal disease treated.
    Stroke incidence
    treatment adherence
    lickert scale (5 levels)
    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)
    Quantification of the evolution of the prescription of antihypertensive drugs in Guiana via data from the Social Security
    stroke in hospital case fatality

    Full Information

    First Posted
    March 3, 2023
    Last Updated
    April 3, 2023
    Sponsor
    Centre Hospitalier de Cayenne
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05814068
    Brief Title
    Active Screening of Arterial Hypertension by Community Outreach Workers in the Cayenne Metropolitan Area to Reduce the Incidence of Cardiovascular Disease
    Official Title
    Active Screening of Arterial Hypertension by Community Outreach Workers in the Cayenne Metropolitan Area to Reduce the Incidence of Cardiovascular Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2025 (Anticipated)
    Study Completion Date
    August 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier de Cayenne

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    High Blood Pressure
    Keywords
    High blood pressure, Precarity, community outreach workers, Cardiovascular disease, Health care

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    diagnosis and treatment of high blood pressure
    Intervention Type
    Drug
    Intervention Name(s)
    antihypertensive drug treatment
    Intervention Description
    Patients with hypertension will be treated for it by their physician
    Primary Outcome Measure Information:
    Title
    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.
    Description
    To compare the incidence of stroke between before and after the intervention
    Time Frame
    5 years
    Secondary Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    treatment adherence
    Description
    lickert scale (5 levels)
    Time Frame
    Inclusion
    Title
    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
    Title
    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
    Title
    stroke in hospital case fatality
    Time Frame
    1, 2, and 3 years after the start of the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adults of at least 18 years old Residents of the agglomeration community of the central coast of French Guiana. Exclusion Criteria: Person who has objected to participating in the study Person under guardianship or curatorship, persons under protective supervision
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mathieu NACHER, PhD
    Phone
    +594594395385
    Email
    mathieu.nacher@ch-cayenne.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Devi ROCHEMONT, PhD
    Phone
    +594594395385
    Email
    devi.rochemont@ch-cayenne.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mathieu NACHER, PhD
    Organizational Affiliation
    Centre Hospitalier de Cayenne
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    21459930
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20736133
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    34450083
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32209060
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33067006
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26822003
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30728033
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    11821324
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22363052
    Citation
    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.
    Results Reference
    background
    Links:
    URL
    http://beh.santepubliquefrance.fr/beh/2020/2-3/2020_2-3_1.html
    Description
    Article - Bulletin épidémiologique hebdomadaire n.d
    URL
    http://doi.org/10.5114/jhi.2018.77646
    Description
    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.

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

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