Impact of Systematic Nursing Orientations in the Reduction of Predicted Cardiovascular Risk in Patients With Coronary Artery Disease. (NERE-CR)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Eneida Rejane Rabelo da Silva, Hospital de Clinicas de Porto Alegre

ClinicalTrials.gov Identifier:

NCT00795626

First received: November 20, 2008

Last updated: February 4, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 20, 2008

Last Updated Date

February 4, 2013

Start Date ^ICMJE

January 2007

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reduction of Predicted Cardiovascular Risk [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Reduction of the risk estimate to cardiovascular events [ Time Frame: one year ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00795626 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Knowledge of the risk factors and the adhesion to pharmacology treatment; Reduction of the modified risk factors in the previous knowledge of patients and their adhesion; [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Knowledge of the risk factors and the adhesion to pharmacology treatment; - Reduction of the modified risk factors in the previous knowledge of patients and their adhesion; [ Time Frame: one year ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Impact of Systematic Nursing Orientations in the Reduction of Predicted Cardiovascular Risk in Patients With Coronary Artery Disease.

Official Title ^ICMJE

Impact of Systematic Nursing Orientations in the Reduction of Predicted Cardiovascular Risk in Patients With Coronary Artery Disease.

Brief Summary

Evaluate the impact of systematic nursing orientations in the reduction of predicted cardiovascular risk in patients with coronary artery disease during four nursing visits for a 1-year period and compare to a group of patients submitted to conventional treatment.

Detailed Description

Assess 184 (two groups) patients during four nursing visits for a 1-year period and compare to a group of patients submitted to conventional treatment. We will evaluate the impact of systematic nursing orientations in the reduction of predicted cardiovascular risk in patients with coronary artery disease.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Heart Disease

Intervention ^ICMJE

Behavioral: Systematic education in the reduction of the risk estimate to cardiovascular events

Systematic education during 4 assessment throughout one year

Study Arm (s)

Experimental: Lifestyle counseling

Two groups:

control - conventional care
intervention - systematic education in the reduction of the risk estimate to cardiovascular events

Intervention: Behavioral: Systematic education in the reduction of the risk estimate to cardiovascular events

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2011

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients of both sexes;
aged 18 years or older;
diagnosed with ACS (unstable angina and acute myocardial infarction with ST segment elevation and without ST segment elevation) with CAD diagnosed by cardiac catheterization or electrocardiogram;
patients have to agree to participate by signing a consent term

Exclusion Criteria:

patients with cognitive deficits;
neurological sequelae;
who are not able to come for visits, or who do not consent to participate in the study.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT00795626

Other Study ID Numbers ^ICMJE

UFRGS and HCPA 06570

Has Data Monitoring Committee

Yes

Responsible Party

Eneida Rejane Rabelo da Silva, Hospital de Clinicas de Porto Alegre

Study Sponsor ^ICMJE

Hospital de Clinicas de Porto Alegre

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Eneida R Rabelo, RN, ScD

Federal University of Rio Grande do Sul Post Grad Prog

Information Provided By

Hospital de Clinicas de Porto Alegre

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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