Program for Cardiovascular Prevention and Randomized Clinical Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Federal University of Rio Grande do Sul.
Recruitment status was  Recruiting
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
  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:


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
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 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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014