The "Know Your Numbers" Program in Atahualpa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01831908
Recruitment Status : Active, not recruiting
First Posted : April 15, 2013
Last Update Posted : March 20, 2018
Universidad de Especialidades del Espíritu Santo
Information provided by (Responsible Party):
Oscar H. Del Brutto, MD, Hospital Clínica Kennedy

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.

Condition or disease Intervention/treatment
Cardiovascular Risk Factors Stroke Ischemic Heart Disease Other: Lifestyle counseling

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The "Know Your Numbers" Program in Atahualpa - An Interventional Study Aimed to Reduce Cardiovascular Diseases and Stroke Burden in Rural Coastal Ecuador.
Actual Study Start Date : February 2014
Primary Completion Date : August 2014
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Lifestyle counseling
These persons will be advised on their cardiovascular status and will receive information on how to improve it.
Other: Lifestyle counseling
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.
No Intervention: People not seeking attention
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

Primary Outcome Measures :
  1. Improvement in cardiovascular health [ Time Frame: 5 year ]

Secondary Outcome Measures :
  1. Reduction in incident cases of stroke [ Time Frame: 5 years ]

Other Outcome Measures:
  1. reduction in incident cases of ischemic heart disease [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01831908

Community Center
Atahualpa, Santa Elena, Ecuador
Sponsors and Collaborators
Hospital Clínica Kennedy
Universidad de Especialidades del Espíritu Santo
Principal Investigator: Oscar H Del Brutto, MD Universidad Espiritu Santo

Responsible Party: Oscar H. Del Brutto, MD, Principal Investigator, The Atahualpa Project, Hospital Clínica Kennedy Identifier: NCT01831908     History of Changes
Other Study ID Numbers: TAP-2013-03
First Posted: April 15, 2013    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Keywords provided by Oscar H. Del Brutto, MD, Hospital Clínica Kennedy:
cardiovascular health, stroke, ischemic heart disease

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Coronary Disease
Heart Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases