The "Know Your Numbers" Program in Atahualpa

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 15, 2014
Last verified: August 2014
  Purpose

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 Intervention
Cardiovascular Risk Factors
Stroke
Ischemic Heart Disease
Other: Lifestyle counseling

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Hospital Clínica Kennedy:

Primary Outcome Measures:
  • Improvement in cardiovascular health [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in incident cases of stroke [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • reduction in incident cases of ischemic heart disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: February 2014
Estimated Study Completion Date: August 2018
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   40 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01831908

Contacts
Contact: Oscar H Del Brutto, MD 593-42285790 oscardelbrutto@hotmail.com
Contact: Mauricio Zambrano, BsC 593-994382668 zamaleon@hotmail.com

Locations
Ecuador
Community Center Recruiting
Atahualpa, Santa Elena, Ecuador
Contact: Oscar H Del Brutto, MD    593-42285790    oscardelbrutto@hotmail.com   
Sub-Investigator: Daniel Tettamanti, MD         
Sub-Investigator: Rocio Santibanez, MD         
Sub-Investigator: Ernesto Penaherrera, MD         
Sponsors and Collaborators
Hospital Clínica Kennedy
Universidad de Especialidades Espiritu Santo
Investigators
Principal Investigator: Oscar H Del Brutto, MD Universidad Espiritu Santo
  More Information

Publications:
Responsible Party: Oscar H. Del Brutto, MD, Principal Investigator, The Atahualpa Project, Hospital Clínica Kennedy
ClinicalTrials.gov Identifier: NCT01831908     History of Changes
Other Study ID Numbers: TAP-2013-03
Study First Received: April 11, 2013
Last Updated: August 15, 2014
Health Authority: Ecuador: Ethical Committee

Keywords provided by Hospital Clínica Kennedy:
cardiovascular health, stroke, ischemic heart disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Stroke
Cerebral Infarction
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 28, 2014