Back to resultsImpact of Systematic Nursing Orientations in the Reduction of Predicted Cardiovascular Risk in Patients With Coronary Artery Disease. (NERE-CR)
Primary Purpose
Coronary Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Systematic education in the reduction of the risk estimate to cardiovascular events
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease focused on measuring nursing education, cardiovascular risk factors, coronary heart disease
Eligibility Criteria
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.
Sites / Locations
- Eneida Rejane Rabelo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lifestyle counseling
Arm Description
Two groups: control - conventional care intervention - systematic education in the reduction of the risk estimate to cardiovascular events
Outcomes
Primary Outcome Measures
Reduction of Predicted Cardiovascular Risk
Secondary Outcome Measures
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;
Full Information
NCT ID
NCT00795626
First Posted
November 20, 2008
Last Updated
February 4, 2013
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT00795626
Brief Title
Impact of Systematic Nursing Orientations in the Reduction of Predicted Cardiovascular Risk in Patients With Coronary Artery Disease.
Acronym
NERE-CR
Official Title
Impact of Systematic Nursing Orientations in the Reduction of Predicted Cardiovascular Risk in Patients With Coronary Artery Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
nursing education, cardiovascular risk factors, coronary heart disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
Two groups:
control - conventional care
intervention - systematic education in the reduction of the risk estimate to cardiovascular events
Intervention Type
Behavioral
Intervention Name(s)
Systematic education in the reduction of the risk estimate to cardiovascular events
Intervention Description
Systematic education during 4 assessment throughout one year
Primary Outcome Measure Information:
Title
Reduction of Predicted Cardiovascular Risk
Time Frame
one year
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eneida R Rabelo, RN, ScD
Organizational Affiliation
Federal University of Rio Grande do Sul Post Grad Prog
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eneida Rejane Rabelo
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035003
Country
Brazil
12. IPD Sharing Statement
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Impact of Systematic Nursing Orientations in the Reduction of Predicted Cardiovascular Risk in Patients With Coronary Artery Disease.
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