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

Sponsor
Centre Hospitalier de Cayenne (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05814068
Collaborator
(none)
50,000
1
27

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: antihypertensive drug treatment
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Active Screening of Arterial Hypertension by Community Outreach Workers in the Cayenne Metropolitan Area to Reduce the Incidence of Cardiovascular Disease
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  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. [5 years]

    To compare the incidence of stroke between before and after the intervention

Secondary Outcome Measures

  1. 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]

  2. 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]

  3. treatment adherence [Inclusion]

    lickert scale (5 levels)

  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) [2 years]

  5. 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]

  6. stroke in hospital case fatality [1, 2, and 3 years after the start of the intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:
  • Person who has objected to participating in the study

  • Person under guardianship or curatorship, persons under protective supervision

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier de Cayenne

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Centre Hospitalier de Cayenne
ClinicalTrials.gov Identifier:
NCT05814068
Other Study ID Numbers:
  • DEPIPREC
First Posted:
Apr 14, 2023
Last Update Posted:
Apr 14, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier de Cayenne
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2023