NCT05814068

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

April 14, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

March 3, 2023

Last Update Submit

April 3, 2023

Conditions

Keywords

High blood pressurePrecaritycommunity outreach workersCardiovascular diseaseHealth care

Outcome Measures

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

    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.

    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

    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

    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)

    2 years

  • Quantification of the evolution of the prescription of antihypertensive drugs in Guiana via data from the Social Security

    Before and 1, 2, and 3 years after the implementation of the intervention

  • +1 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

diagnosis and treatment of high blood pressure

Drug: antihypertensive drug treatment

Interventions

Patients with hypertension will be treated for it by their physician

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 21459930BACKGROUND
  • 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.

    PMID: 20736133BACKGROUND
  • 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.

    PMID: 34450083BACKGROUND
  • 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.

    PMID: 32209060BACKGROUND
  • 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.

    PMID: 33067006BACKGROUND
  • 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.

    PMID: 26822003BACKGROUND
  • 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.

    PMID: 30728033BACKGROUND
  • 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.

    PMID: 11821324BACKGROUND
  • 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.

    PMID: 22363052BACKGROUND

Related Links

MeSH Terms

Conditions

HypertensionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

  • Mathieu NACHER, PhD

    Centre Hospitalier de Cayenne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2023

First Posted

April 14, 2023

Study Start

May 1, 2023

Primary Completion

May 1, 2025

Study Completion

August 1, 2025

Last Updated

April 14, 2023

Record last verified: 2023-02