Health and Cardiovascular Risk Factors in Slums.

Cardiovascular Diseases Clinical Trial

Official title:

Health and Cardiovascular Risk Factors Survey in the 31's Slum.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03734939
• Other study ID #: 0004
• Status: Active, not recruiting
• Start date: November 7, 2018
• Est. completion date: December 20, 2022

Study information

• Verified date: May 2021
• Source: Fundacion GESICA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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:

1. To measure the prevalence of cardiovascular risk factors in a representative sample of the villa 31 (an urban slum from Buenos Aires city).

2. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2265
• Est. completion date: December 20, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Factor

Intervention

Other:
• None intervention is planned.
None intervention is planned, just a survey.

Locations

Country	Name	City	State
Argentina	Fundación GESICA	Ciudad Autónoma de Buenos Aire	Buenos Aires

Sponsors (3)

Lead Sponsor	Collaborator
Fundacion GESICA	Corriente Salvador Maza, Escuela de Psicología Social Pichon Riviere

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypertension	Blood pressure >=140/90 mmHg or being taking antihypertensive medication.	Through study completion, an average of 3 months
Primary	Smoking	Percentage of participants that self-report current smoking	Through study completion, an average of 3 months
Primary	Hypercholesterolemia	Self-reported plasma high cholesterol levels.	Through study completion, an average of 3 months
Primary	Diabetes	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
Primary	Self-perceived health	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	Previous myocardial infarction	Self-reported history of myocardial infarction.	through study completion, an average of 3 months
Secondary	Previous stroke	Self-reported history of stroke.	through study completion, an average of 3 months
Secondary	Physical activity	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").	Through study completion, an average of 3 months
Secondary	Healthy diet	Self-reported consumption of vegetables and fruits.	through study completion, an average of 3 months
Secondary	Body mass index	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