The "Know Your Numbers" Program in Atahualpa

The "Know Your Numbers" Program in Atahualpa - An Interventional Study Aimed to Reduce Cardiovascular Diseases and Stroke Burden in Rural Coastal Ecuador.

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Ischemic Heart Disease; Cardiovascular Risk Factors
• Intervention / Treatment: 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
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ecuador
  • Santa Elena
    • Atahualpa, Santa Elena, Ecuador
      • Community center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in cardiovascular health	5 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction in incident cases of stroke	5 years

Other Outcome Measures

Outcome Measure	Time Frame
reduction in incident cases of ischemic heart disease	5 years

Collaborators and Investigators

• Sponsor: Hospital Clínica Kennedy
• Collaborators: Universidad de Especialidades Espiritu Santo
• Investigators: Principal Investigator: Oscar H Del Brutto, MD, Universidad Espiritu Santo

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 2, 2019

Study Registration Dates

• First Submitted: April 11, 2013
• First Submitted That Met QC Criteria: April 11, 2013
• First Posted (Estimate): April 15, 2013

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: cardiovascular health, stroke, ischemic heart disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Stroke; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: TAP-2013-03