NCT01831908

Brief Summary

Persons voluntarily attending the Community Center of the Atahualpa Project during one calendar year will be evaluated by trained personnel to check their cardiovascular health status. A chart with information of healthy behaviors as well as the numbers of the person's blood pressure, fasting glucose, and total cholesterol levels will be given. Persons who sign the informed consent will be visited at their homes after 3 months and than every year up to five years. The idea is to check whether the person followed our advises and if that compliance iis associated with improvement in the cardiovascular status or with a decreased incidence of stroke and ischemic heart disease, when compared with persons who did not attend the community center or those who did not follow our advices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 11, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2019

Completed
Last Updated

August 6, 2019

Status Verified

April 1, 2018

Enrollment Period

6 months

First QC Date

April 11, 2013

Last Update Submit

August 5, 2019

Conditions

Cardiovascular Risk FactorsStrokeIschemic Heart Disease

Keywords

cardiovascular health, stroke, ischemic heart disease

Outcome Measures

Primary Outcomes (1)

  • Improvement in cardiovascular health

    5 year

Secondary Outcomes (1)

  • Reduction in incident cases of stroke

    5 years

Other Outcomes (1)

  • reduction in incident cases of ischemic heart disease

    5 years

Study Arms (2)

Lifestyle counseling

SHAM COMPARATOR

These persons will be advised on their cardiovascular status and will receive information on how to improve it.

Other: Lifestyle counseling

People not seeking attention

NO INTERVENTION

Evaluation of cardiovascular health status will be performed in these persons as part of yearly door-to-door survey that will perform in Atahualpa up to the end of the study

Interventions

Lifestyle counselingOTHER

People attending the community center will be provided with information on their health problems and will receive advise on how to improve blood pressure, glucose and cholesterol levels.

Lifestyle counseling

Eligibility Criteria

Age40 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Atahualpa residents aged 40 years or more who seek for information at the Atahualpa Community Center and sign the informed consent.

You may not qualify if:

  • People not attending the Community Center or not signing the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Center

Atahualpa, Santa Elena, Ecuador

Location

Related Publications (3)

  • Del Brutto OH, Penaherrera E, Ochoa E, Santamaria M, Zambrano M, Del Brutto VJ; Atahualpa Project Investigators. Door-to-door survey of cardiovascular health, stroke, and ischemic heart disease in rural coastal Ecuador--the Atahualpa Project: methodology and operational definitions. Int J Stroke. 2014 Apr;9(3):367-71. doi: 10.1111/ijs.12030. Epub 2013 Mar 19.

    PMID: 23506643BACKGROUND

  • Del Brutto OH, Dong C, Rundek T, Elkind MS, Del Brutto VJ, Sacco RL. Cardiovascular health status among Caribbean Hispanics living in Northern Manhattan and Ecuadorian natives/mestizos in rural coastal Ecuador: a comparative study. J Community Health. 2013 Aug;38(4):634-41. doi: 10.1007/s10900-013-9658-0.

    PMID: 23456686BACKGROUND

  • Del Brutto OH, Santamaria M, Ochoa E, Penaherrera E, Santibanez R, Pow-Chon-Long F, Zambrano M, Del Brutto VJ. Population-based study of cardiovascular health in Atahualpa, a rural village of coastal Ecuador. Int J Cardiol. 2013 Sep 30;168(2):1618-20. doi: 10.1016/j.ijcard.2013.01.017. Epub 2013 Feb 11. No abstract available.

    PMID: 23410492BACKGROUND

MeSH Terms

Conditions

StrokeMyocardial Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHeart Diseases

Study Officials

  • Oscar H Del Brutto, MD

    Universidad Espiritu Santo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, The Atahualpa Project

Study Record Dates

First Submitted

April 11, 2013

First Posted

April 15, 2013

Study Start

February 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 2, 2019

Last Updated

August 6, 2019

Record last verified: 2018-04

Locations

EC(1)