NCT00795626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

4.3 years

First QC Date

November 20, 2008

Last Update Submit

February 4, 2013

Conditions

Coronary Heart Disease

Keywords

nursing educationcardiovascular risk factorscoronary heart disease

Outcome Measures

Primary Outcomes (1)

  • Reduction of Predicted Cardiovascular Risk

    one year

Secondary Outcomes (1)

  • 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;

    one year

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL

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

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

Interventions

Systematic education in the reduction of the risk estimate to cardiovascular eventsBEHAVIORAL

Systematic education during 4 assessment throughout one year

Lifestyle counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eneida Rejane Rabelo

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Eneida R Rabelo, RN, ScD

    Federal University of Rio Grande do Sul Post Grad Prog

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD.

Study Record Dates

First Submitted

November 20, 2008

First Posted

November 21, 2008

Study Start

January 1, 2007

Primary Completion

May 1, 2011

Study Completion

July 1, 2011

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

BR(1)