- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03734939
Health and Cardiovascular Risk Factors in Slums.
Health and Cardiovascular Risk Factors Survey in the 31's Slum.
Cardiovascular risk factors and disease burden has been showed to affect more deeply to poorer populations. People who live in slums are the most vulnerable subgroup in the populations where, paradoxically scarcity of data exists on risk factors and cardiovascular disease burden.
Our study aim to describe the prevalence of cardiovascular risk factors and cardiovascular disease burden in a representative sample of an urban slum of Buenos Aires city, using validated questions from the National Risk Factors Survey (edition 2013). Also, the investigators will measure blood pressure and cardiac rate to all study participants.
Study Overview
Status
Intervention / Treatment
Detailed Description
Cardiovascular risk factors and disease burden has been showed to affect more deeply to poorer populations. People who live in slums are the most vulnerable subgroup in the populations where, paradoxically scarcity of data exists on risk factors and cardiovascular disease burden.
Hypothesis: the prevalence of modifiable cardiovascular risk factors in an urban slum from Buenos Aires city is higher than the rest of the country and, consequently requires a distinctive management approach.
Objectives:
- To measure the prevalence of cardiovascular risk factors in a representative sample of the villa 31 (an urban slum from Buenos Aires city).
- To measure the self-perceived health in a representative sample of the villa 31 (urban slum from Buenos Aires city).
Design: observational study. Survey. Procedures: the survey will be conducted by neighbors from the slum that received specific training as community health workers and were trained on the use of the survey questionnaire and for blood pressure measuring.
Sampling: representative samples of slum population will be obtained using probabilistic, multi-staged sampling methods.
Blood pressure measures: blood pressure will be measured using automatic blood pressure monitoring device with appropriate cuff sizes.
Statistical analyses: categorical variables will be expressed as numbers and percentages, and continuous variable as means and standard deviations or medians and interquartile ranges. Between groups comparisons will be conducted using chi2 test for categorical variables and T test or Mann-Whitney U's test for continuous variables. To compare the prevalence of risk factors with the rest of the country, the database will be jointed with the national risk factor survey (publicly available). All analyses will be weighted to account for the sampling method.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
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Buenos Aires
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Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina, C1034ACD
- Fundación GESICA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria: >= 18 years. Sign the informed consent.
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Exclusion Criteria: Unable to answer the survey. Unwilling to participate.
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Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hypertension
Time Frame: Through study completion, an average of 3 months
|
Blood pressure >=140/90 mmHg or being taking antihypertensive medication.
|
Through study completion, an average of 3 months
|
Smoking
Time Frame: Through study completion, an average of 3 months
|
Percentage of participants that self-report current smoking
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Through study completion, an average of 3 months
|
Hypercholesterolemia
Time Frame: Through study completion, an average of 3 months
|
Self-reported plasma high cholesterol levels.
|
Through study completion, an average of 3 months
|
Diabetes
Time Frame: Through study completion, an average of 3 months
|
Percentage of participants that self-report as had been diagnosed as diabetic or receiving medical therapy for diabetes.
|
Through study completion, an average of 3 months
|
Self-perceived health
Time Frame: Through study completion, an average of 3 months
|
Percentage of participants that report their health status as self-perceived in a 5-points Likert' scale from "Excellent" to "Bad"
|
Through study completion, an average of 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Previous myocardial infarction
Time Frame: through study completion, an average of 3 months
|
Self-reported history of myocardial infarction.
|
through study completion, an average of 3 months
|
Previous stroke
Time Frame: through study completion, an average of 3 months
|
Self-reported history of stroke.
|
through study completion, an average of 3 months
|
Physical activity
Time Frame: Through study completion, an average of 3 months
|
Percentage of participants with self-reported physical activity levels in a Likert' scale (from "Less than 10 min/week" to "Equal or more than 150 min/week").
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Through study completion, an average of 3 months
|
Healthy diet
Time Frame: through study completion, an average of 3 months
|
Self-reported consumption of vegetables and fruits.
|
through study completion, an average of 3 months
|
Body mass index
Time Frame: through study completion, an average of 3 months
|
Body weight divided by the height squared in meters (both body weight and height as self-reported.
|
through study completion, an average of 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Javier Mariani, MD, Fundación GESICA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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