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The "Know Your Numbers" Program in Atahualpa

Primary Purpose

Cardiovascular Risk Factors, Stroke, Ischemic Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Ecuador
Study Type
Interventional
Intervention
Lifestyle counseling
Sponsored by
Hospital Clínica Kennedy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Risk Factors focused on measuring cardiovascular health, stroke, ischemic heart disease

Eligibility Criteria

40 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Community Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

No Intervention

Arm Label

Lifestyle counseling

People not seeking attention

Arm Description

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

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

Outcomes

Primary Outcome Measures

Improvement in cardiovascular health

Secondary Outcome Measures

Reduction in incident cases of stroke

Full Information

First Posted
April 11, 2013
Last Updated
August 5, 2019
Sponsor
Hospital Clínica Kennedy
Collaborators
Universidad de Especialidades Espiritu Santo
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1. Study Identification

Unique Protocol Identification Number
NCT01831908
Brief Title
The "Know Your Numbers" Program in Atahualpa
Official Title
The "Know Your Numbers" Program in Atahualpa - An Interventional Study Aimed to Reduce Cardiovascular Diseases and Stroke Burden in Rural Coastal Ecuador.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clínica Kennedy
Collaborators
Universidad de Especialidades Espiritu Santo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Campaigns aimed to increase the level of awareness on cardiovascular risk factors may encourage people to change their lifestyles and to increase compliance with medication. This intervention has been called the "know your numbers program" and has been tested in developed countries. No study have evaluated the efficacy of this program in reducing the prevalence of ischemic heart disease and stroke on the long-term follow-up, and this program has not been applied to people living in rural areas of developing countries. During the study years, a community center of the Atahualpa Project will be open and stuffed with trained paramedical personnel that will attend people that voluntarily look for information. All these persons will be invited to participate in the "know your numbers" program, and those who sign the informed consent form will be enrolled in the program. Recruitment will be during one calendar year to assure the inclusion of a significant sample size of the population. As part of the initial visit, the CVH status of all individuals will be evaluated. Thereafter, persons will be informed on their health status and the best ways to improve it according to specific situations. Those who merit treatment for a given condition will be instructed to go to the physician for proper advice and prescription. A chart containing information on stroke and ischemic heart disease warning signs, as well as on healthy behaviors will be provided to all persons. All enrolled persons will be visited at their homes three months after the initial visit to the community center, and then, every year up to five years. We will evaluate whether the person followed our advices or the reasons for poor compliance. Persons will be asked to tell us if they remember the ischemic heart disease and stroke warning signs. Anthropometric parameters, blood pressure, total cholesterol and fasting glucose levels will be recorder at every visit and, again, any specific advice to improve "their numbers" or to seek for medical attention will be given. By the end of the study, the investigators will be able to correlate the CVH status of the person as well as the occurrence of vascular outcomes or death according to whether our advices were followed or not. Statistical analysis will be directed to refute the null hypothesis that this intervention does not improve the CVH and does not reduce the risk of stroke or ischemic heart disease

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factors, Stroke, Ischemic Heart Disease
Keywords
cardiovascular health, stroke, ischemic heart disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Sham Comparator
Arm Description
These persons will be advised on their cardiovascular status and will receive information on how to improve it.
Arm Title
People not seeking attention
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Lifestyle counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in cardiovascular health
Time Frame
5 year
Secondary Outcome Measure Information:
Title
Reduction in incident cases of stroke
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
reduction in incident cases of ischemic heart disease
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Atahualpa residents aged 40 years or more who seek for information at the Atahualpa Community Center and sign the informed consent. Exclusion Criteria: People not attending the Community Center or not signing the informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar H Del Brutto, MD
Organizational Affiliation
Universidad Espiritu Santo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Center
City
Atahualpa
State/Province
Santa Elena
Country
Ecuador

12. IPD Sharing Statement

Citations:
PubMed Identifier
23506643
Citation
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.
Results Reference
background
PubMed Identifier
23456686
Citation
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.
Results Reference
background
PubMed Identifier
23410492
Citation
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.
Results Reference
background

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The "Know Your Numbers" Program in Atahualpa

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