Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Program for Cardiovascular Prevention and Randomized Clinical Trial

This study has been completed.
Hospital Moinhos de Vento
Information provided by (Responsible Party):
Fabiana Viegas Raimundo, Federal University of Rio Grande do Sul Identifier:
First received: September 22, 2012
Last updated: January 14, 2016
Last verified: January 2016
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.

Condition Intervention
Behavioral: Support for the Family Health Team

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Management Models for Cardiovascular Risk Reduction in Primary for Brazil: Developing a Program for Cardiovascular Prevention and Randomized Clinical Trial

Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: Change from baseline in Systolic Blood Pressure at 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 256
Study Start Date: May 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01696318

Hospital Moinhos de Vento
Porto Alegre, RS, Brazil, 90035-001
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Hospital Moinhos de Vento
Study Director: Carisi Polanczyc, PhD UFRGS/HMV
  More Information

Responsible Party: Fabiana Viegas Raimundo, PhD, Federal University of Rio Grande do Sul Identifier: NCT01696318     History of Changes
Other Study ID Numbers: U1111-1134-6977  HMV - 680 
Study First Received: September 22, 2012
Last Updated: January 14, 2016
Health Authority: Ministry of Health:Brazil
National Council for Scientific and Technological Development:Brazil processed this record on January 18, 2017