Coronary Heart DiseaseNERE-CRNCT00795626
Impact of Systematic Nursing Orientations in the Reduction of Predicted Cardiovascular Risk in Patients With Coronary Artery Disease.
A study testing Systematic education in the reduction of the risk estimate to cardiovascular events in people with Coronary Heart Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Systematic education in the reduction of the risk estimate to cardiovascular events
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2007to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients with cognitive deficits;
- neurological sequelae;
- who are not able to come for visits, or who do not consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Coronary Heart Disease
- Being tested
- Systematic education in the reduction of the risk estimate to cardiovascular events
- Keywords
- nursing education, cardiovascular risk factors, coronary heart disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic education in the reduction of the risk estimate to cardiovascular eventsBehavioural
Systematic education during 4 assessment throughout one year
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Two groups:
* control - conventional care
* intervention - systematic education in the reduction of the risk estimate to cardiovascular events Receives: Behavioral: Systematic education in the reduction of the risk estimate to cardiovascular events |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Predicted Cardiovascular Risk
Measured: 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;
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startJan 2007
- Primary completionMay 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eneida Rejane Rabelo da Silva, Hospital de Clinicas de Porto Alegre
- Investigators
- Eneida R Rabelo, RN, ScD, Principal investigator, Federal University of Rio Grande do Sul Post Grad Prog
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795626
- Sponsor's protocol ID
- UFRGS and HCPA 06570
- Acronym
- NERE-CR
- Status last verified
- Feb 2013
- First submitted
- 20 Nov 2008
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Systematic Nursing Orientations in the Reduction of Predicted Cardiovascular Risk in Patients With Coronary Artery Disease.
- ClinicalTrials.gov ID
- NCT00795626
- Acronym / sponsor ID
- NERE-CR / UFRGS and HCPA 06570
- Conditions
- Coronary Heart Disease
- Keywords
- nursing education, cardiovascular risk factors, coronary heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- May 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Systematic education in the reduction of the risk estimate to cardiovascular eventsTwo groups: * control - conventional care * intervention - systematic education in the reduction of the risk estimate to cardiovascular events |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- patients with cognitive deficits;
- neurological sequelae;
- who are not able to come for visits, or who do not consent to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic education in the reduction of the risk estimate to cardiovascular eventsSystematic education during 4 assessment throughout one year | Behavioural | Lifestyle counseling |
Primary outcome
Reduction of Predicted Cardiovascular Risk
Time frame: one year
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
Related trials for Coronary Heart Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eneida R Rabelo, RN, ScD principal investigator
Federal University of Rio Grande do Sul Post Grad Prog
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic education in the reduction of the risk estimate to cardiovascular events in people with Coronary Heart Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Predicted Cardiovascular Risk (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2013.