The "Know Your Numbers" Program in Atahualpa

Sponsor
Hospital Clínica Kennedy (Other)
Overall Status
Completed
CT.gov ID
NCT01831908
Collaborator
Universidad de Especialidades Espiritu Santo (Other)
350
1
2
66
5.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Lifestyle counseling
N/A

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 Design

Study Type:
Interventional
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 :
Feb 1, 2014
Actual Primary Completion Date :
Aug 1, 2014
Actual Study Completion Date :
Aug 2, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Improvement in cardiovascular health [5 year]

Secondary Outcome Measures

  1. Reduction in incident cases of stroke [5 years]

Other Outcome Measures

  1. reduction in incident cases of ischemic heart disease [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 95 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Community Center Atahualpa Santa Elena Ecuador

Sponsors and Collaborators

  • Hospital Clínica Kennedy
  • Universidad de Especialidades Espiritu Santo

Investigators

  • Principal Investigator: Oscar H Del Brutto, MD, Universidad Espiritu Santo

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Oscar H. Del Brutto, MD, Principal Investigator, The Atahualpa Project, Hospital Clínica Kennedy
ClinicalTrials.gov Identifier:
NCT01831908
Other Study ID Numbers:
  • TAP-2013-03
First Posted:
Apr 15, 2013
Last Update Posted:
Aug 6, 2019
Last Verified:
Apr 1, 2018
Keywords provided by Oscar H. Del Brutto, MD, Principal Investigator, The Atahualpa Project, Hospital Clínica Kennedy
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 6, 2019