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Program for Cardiovascular Prevention and Randomized Clinical Trial

This study is currently recruiting participants.
Verified September 2012 by Federal University of Rio Grande do Sul
Sponsor:
Collaborator:
Instituto de Educação e Pesquisa do Hospital Moinhos de Vento
Information provided by (Responsible Party):
Fabiana Viegas Raimundo, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT01696318
First received: September 22, 2012
Last updated: September 28, 2012
Last verified: September 2012
History of Changes
  Purpose

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
Hypertension
 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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Estimated Enrollment: 258
Study Start Date: January 2012
Estimated Primary Completion Date: September 2012 (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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696318

Contacts
Contact: Regina Kuhmmer, PhD 55 51 98164071 reginakuhmmer@gmail.com

Locations
Brazil
Hospital Moinhos de Vento Recruiting
Porto Alegre, RS, Brazil, 90035-001
Contact: Regina Kuhmmer, PhD     55 51 98164071     reginakuhmmer@gmail.com    
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Instituto de Educação e Pesquisa do Hospital Moinhos de Vento
Investigators
Study Director: Carisi Polanczyc, PhD UFRGS/HMV
  More Information

No publications provided

Responsible Party: Fabiana Viegas Raimundo, PhD, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01696318     History of Changes
Other Study ID Numbers: U1111-1134-6977, HMV - 680
Study First Received: September 22, 2012
Last Updated: September 28, 2012
Health Authority: Conselho Nacional de Saúde/Ministério da Saúde:Brazil

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013