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

April 3, 2023 updated by: Centre Hospitalier de Cayenne
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
diagnosis and treatment of high blood pressure
Drug: antihypertensive drug treatment
Patients with hypertension will be treated for it by their physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
lickert scale (5 levels)
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
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
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
1, 2, and 3 years after the start of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Cayenne

Investigators

  • Principal Investigator: Mathieu NACHER, PhD, Centre Hospitalier de Cayenne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

May 1, 2025

Study Completion (Anticipated)

August 1, 2025

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEPIPREC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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