- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02230150
ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE - ADhesion-HF (ADhesion-HF)
August 29, 2014 updated by: Márcia Maria Carneiro Oliveira, Federal University of Bahia
The purpose of this study is to verify the impact of the educational intervention in the adhesion to therapeutic strategies for patients with heart failure.
Study Overview
Detailed Description
- Characterize the socio-demographic and clinical aspects of heart failure patients;
- Awareness before and after nursing consultation, in relation to diet for heart failure, liquid and weight, general heart failure information, medication, physical activity, measures to improve disease control, signs of decompensated heart failure;
- Adhesion of patients before and after nursing consultation, related to medication, liquid and weight, use of alcohol and importance of returning for consultation and exams.
- Evaluated the impact of educational intervention at the levels of NT-proBNP, urea, creatinine, sodium, potassium, before and after nursing consultation;
- The 6 minute walk test performance before and after nursing consultation;
- The distance covered and time of the 6 minute walk test, until fatigue in heart failure patients before and after nursing consultation;
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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BA
-
Salvador, BA, Brazil, 41120-700
- Hospital Ana Nery
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- During the first phase of the study all the heart failure patients with ventricular ejection fraction of up to 49% shall be included (confirmed through ECOTT performed during the past year). All patients inserted had systolic heart failure and were scheduled and which agreed to take part of the research, signing a term of informed consent.
Exclusion Criteria:
- Individuals with cognitive deficit, first outpatient medical consultation, suffered AMI (acute myocardial infarction) within the last 3 months or a stroke, post-operative of cardiac surgery, patients with chronic obstructive pulmonary disease (COPD), orthopedic problems, patients over the age of 80 and those that do not accept to participate of the research.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE
Time Frame: 1 month
|
Verify the impact of the educational intervention in the adhesion to therapeutic strategies for patients with heart failure.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in biomarkers: Nt-proBNP, sodium, potassium, urea and creatinine
Time Frame: 1 month
|
changes in biomarkers: Nt-proBNP, sodium, potassium, urea and creatinine before and after nursing consultation
|
1 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
performance in the six minutes walk test
Time Frame: 1 month
|
monitor the difference in performance of the 6-minute walk test in adherent and non-adherent
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Márcia M Carneiro Oliveira
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
August 20, 2014
First Submitted That Met QC Criteria
August 29, 2014
First Posted (Estimate)
September 3, 2014
Study Record Updates
Last Update Posted (Estimate)
September 3, 2014
Last Update Submitted That Met QC Criteria
August 29, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADhesion-HF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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