Cardiovascular Risk FactorNCT03734939
Health and Cardiovascular Risk Factors in Slums.
An observational study of Cardiovascular Risk Factor and Cardiovascular Diseases, run by Fundacion GESICA at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Cardiovascular Diseases
- What is being tested?
- None intervention is planned.
- How many people
- 2,265 participants
- Where
- 1 siteArgentina
- Study dates
- 7 Nov 2018to 20 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adults of the slum that accept to participate in the survey.
Who may be able to join
- -
- Exclusion Criteria: Unable to answer the survey. Unwilling to participate.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Fundación GESICA
Ciudad Autónoma de Buenos Aire, Buenos Aires, C1034ACD
About this study
Official title: 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.
Read the 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.
- Being tested
- None intervention is planned.
- Keywords
- cardiovascular risk factor, Slums, survey, cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None intervention is planned.Other
None intervention is planned, just a survey.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension
Blood pressure >=140/90 mmHg or being taking antihypertensive medication.
Measured: Through study completion, an average of 3 months
Smoking
Percentage of participants that self-report current smoking
Measured: Through study completion, an average of 3 months
Hypercholesterolemia
Self-reported plasma high cholesterol levels.
Measured: Through study completion, an average of 3 months
Diabetes
Percentage of participants that self-report as had been diagnosed as diabetic or receiving medical therapy for diabetes.
Measured: Through study completion, an average of 3 months
Self-perceived health
Percentage of participants that report their health status as self-perceived in a 5-points Likert' scale from "Excellent" to "Bad"
Measured: Through study completion, an average of 3 months
Secondary outcomes (5)
Previous myocardial infarction
Self-reported history of myocardial infarction.
Measured: through study completion, an average of 3 months
Previous stroke
Self-reported history of stroke.
Measured: through study completion, an average of 3 months
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").
Measured: Through study completion, an average of 3 months
Healthy diet
Self-reported consumption of vegetables and fruits.
Measured: through study completion, an average of 3 months
Body mass index
Body weight divided by the height squared in meters (both body weight and height as self-reported.
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start7 Nov 2018
- Primary completion1 Dec 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion GESICA
- Sponsor type
- University, hospital or other
- Collaborators
- Escuela de Psicología Social Pichon Riviere, Corriente Salvador Maza
- Responsible party
- Sponsor
- Investigators
- Javier Mariani, MD, Principal investigator, Fundación GESICA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734939
- Sponsor's protocol ID
- 0004
- Status last verified
- May 2021
- First submitted
- 11 Oct 2018
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Cardiovascular Risk Factors Survey in the 31's Slum.
- ClinicalTrials.gov ID
- NCT03734939
- Acronym / sponsor ID
- 0004
- Keywords
- cardiovascular risk factor, Slums, survey, cardiovascular disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,265 participants (estimated)
- Lead sponsor
- Fundacion GESICAUniversity, hospital or other
- Collaborators
- Escuela de Psicología Social Pichon Riviere, Corriente Salvador Maza
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adults of the slum that accept to participate in the survey.
Key inclusion criteria (3 listed)
- -
- Exclusion Criteria: Unable to answer the survey. Unwilling to participate.
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None intervention is planned.None intervention is planned, just a survey. | Other | – |
Primary outcome
Hypertension
Time frame: Through study completion, an average of 3 months
Blood pressure >=140/90 mmHg or being taking antihypertensive medication.
Smoking
Time frame: Through study completion, an average of 3 months
Percentage of participants that self-report current smoking
Hypercholesterolemia
Time frame: Through study completion, an average of 3 months
Self-reported plasma high cholesterol levels.
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.
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"
5 secondary outcomes
Previous myocardial infarction
Time frame: through study completion, an average of 3 months
Previous stroke
Time frame: through study completion, an average of 3 months
Physical activity
Time frame: Through study completion, an average of 3 months
Healthy diet
Time frame: through study completion, an average of 3 months
Body mass index
Time frame: through study completion, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Mariani, MD principal investigator
Fundación GESICA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk Factor and Cardiovascular Diseases, run by Fundacion GESICA at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertension (time frame: Through study completion, an average of 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.