Program for Cardiovascular Prevention and Randomized Clinical Trial

January 14, 2016 updated by: Fabiana Viegas Raimundo, Federal University of Rio Grande do Sul

Management Models for Cardiovascular Risk Reduction in Primary for Brazil: Developing a Program for Cardiovascular Prevention and Randomized Clinical Trial

Develop and evaluate a model of organization and management in the management of patients with cardiovascular risk factors (hypertension, diabetes mellitus, smoking, obesity, physical inactivity, dyslipidemia and family history) in primary care aimed at the compliance, control and treatment effectiveness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-001
        • Hospital Moinhos de Vento

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of hypertension (> 140/90 mmHg)
  • Age > 40 years
  • Sitting: USF da Restinga e Extremo Sul - USF Chapéu do Sol and USF Paulo Viaro

Exclusion Criteria:

  • Institutionalized individuals
  • Patients with mental illness or disabling chronic illnesses
  • Users of health services belonging to the supplementary health
  • Individuals with life expectancy less than 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Educational program
Educational Program with Professional Physical Education, Pharmacist and Nutritionist
Experimental: Educational program and individual care
Educational program and individual care with professional Physical Education; Pharmacist and Nutritionist
Behavioral: Support for the Family Health Team
Participation in physical educator, dietitian and pharmacist in primary health care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood Pressure
Time Frame: Change from baseline in Systolic Blood Pressure at 6 months
Change from baseline in Systolic Blood Pressure at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Collaborators

Hospital Moinhos de Vento

Investigators

  • Study Director: Carisi Polanczyc, PhD, UFRGS/HMV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 22, 2012

First Submitted That Met QC Criteria

September 28, 2012

First Posted (Estimate)

October 1, 2012

Study Record Updates

Last Update Posted (Estimate)

January 15, 2016

Last Update Submitted That Met QC Criteria

January 14, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1134-6977
  • HMV - 680 (Other Identifier: Comite de Ética em Pesquisa Hospital Moinhos de Vento)

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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