The "Know Your Numbers" Program in Atahualpa

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Hospital Clínica Kennedy
Sponsor:
Collaborator:
Universidad de Especialidades Espiritu Santo
Information provided by (Responsible Party):
Oscar H. Del Brutto, MD, Hospital Clínica Kennedy
ClinicalTrials.gov Identifier:
NCT01831908
First received: April 11, 2013
Last updated: November 24, 2013
Last verified: November 2013

April 11, 2013
November 24, 2013
February 2014
August 2014   (final data collection date for primary outcome measure)
Improvement in cardiovascular health [ Time Frame: 5 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01831908 on ClinicalTrials.gov Archive Site
Reduction in incident cases of stroke [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
reduction in incident cases of ischemic heart disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
 
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.

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

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Cardiovascular Risk Factors
  • Stroke
  • Ischemic Heart Disease
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.
  • Sham Comparator: Lifestyle counseling
    These persons will be advised on their cardiovascular status and will receive information on how to improve it.
    Intervention: Other: Lifestyle counseling
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
300
August 2018
August 2014   (final data collection date for primary outcome measure)

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.
Both
40 Years to 95 Years
Yes
Contact: Oscar H Del Brutto, MD 593-42285790 oscardelbrutto@hotmail.com
Contact: Mauricio Zambrano, BsC 593-994382668 zamaleon@hotmail.com
Ecuador
 
NCT01831908
TAP-2013-03
No
Oscar H. Del Brutto, MD, Hospital Clínica Kennedy
Hospital Clínica Kennedy
Universidad de Especialidades Espiritu Santo
Principal Investigator: Oscar H Del Brutto, MD Universidad Espiritu Santo
Hospital Clínica Kennedy
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP