Ignite Creation Date:
2024-05-06 @ 1:32 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01831908
Status:
COMPLETED
Last Update Posted:
2019-08-06
First Post:
2013-04-11
Brief Title:
The Know Your Numbers Program in Atahualpa
Sponsor:
Hospital Clínica Kennedy
Organization:
Hospital Clínica Kennedy
Study Overview
Official Title:
The Know Your Numbers Program in Atahualpa - An Interventional Study Aimed to Reduce Cardiovascular Diseases and Stroke Burden in Rural Coastal Ecuador
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 persons 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None