Back to resultsADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE - ADhesion-HF (ADhesion-HF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Adhesion-HF
Sponsored by
About this trial
This is an interventional prevention trial for Heart Failure focused on measuring Adhesion, Knowledge, Nursing
Eligibility Criteria
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.
Sites / Locations
- Hospital Ana Nery
Outcomes
Primary Outcome Measures
ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE
Verify the impact of the educational intervention in the adhesion to therapeutic strategies for patients with heart failure.
Secondary Outcome Measures
changes in biomarkers: Nt-proBNP, sodium, potassium, urea and creatinine
changes in biomarkers: Nt-proBNP, sodium, potassium, urea and creatinine before and after nursing consultation
Full Information
NCT ID
NCT02230150
First Posted
August 20, 2014
Last Updated
August 29, 2014
Sponsor
Federal University of Bahia
1. Study Identification
Unique Protocol Identification Number
NCT02230150
Brief Title
ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE - ADhesion-HF
Acronym
ADhesion-HF
Official Title
ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE - ADhesion-HF
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Bahia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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;
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Adhesion, Knowledge, Nursing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Adhesion-HF
Intervention Description
The hypothesis that was investigated is whether the nursing consultation improves therapeutic strategies for membership, adherence to self-care, improved levels of NT-proBNP improves performance in 6-minute walk test, monitoring of biomarkers of laboratory tests (sodium , potassium, urea, creatinine and NT-proBNP) frequent occurrence of readmissions and mortality in patients with heart failure after 1 month.
Primary Outcome Measure Information:
Title
ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE
Description
Verify the impact of the educational intervention in the adhesion to therapeutic strategies for patients with heart failure.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
changes in biomarkers: Nt-proBNP, sodium, potassium, urea and creatinine
Description
changes in biomarkers: Nt-proBNP, sodium, potassium, urea and creatinine before and after nursing consultation
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
performance in the six minutes walk test
Description
monitor the difference in performance of the 6-minute walk test in adherent and non-adherent
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Márcia M Carneiro Oliveira
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Ana Nery
City
Salvador
State/Province
BA
ZIP/Postal Code
41120-700
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE - ADhesion-HF
We'll reach out to this number within 24 hrs