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

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
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
NCT ID
NCT05814068
First Posted
March 3, 2023
Last Updated
April 3, 2023
Sponsor
Centre Hospitalier de Cayenne
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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