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ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE - ADhesion-HF (ADhesion-HF)

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ClinicalTrials.gov Identifier: NCT02230150
Recruitment Status : Completed
First Posted : September 3, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Márcia Maria Carneiro Oliveira, Federal University of Bahia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Adhesion-HF Not Applicable

Detailed Description:
  1. Characterize the socio-demographic and clinical aspects of heart failure patients;
  2. 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;
  3. 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.
  4. Evaluated the impact of educational intervention at the levels of NT-proBNP, urea, creatinine, sodium, potassium, before and after nursing consultation;
  5. The 6 minute walk test performance before and after nursing consultation;
  6. The distance covered and time of the 6 minute walk test, until fatigue in heart failure patients before and after nursing consultation;
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE - ADhesion-HF
Study Start Date : December 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

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Arms and Interventions
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Intervention Details:
  • Behavioral: Adhesion-HF
    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.

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02230150


Locations
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Brazil
Hospital Ana Nery
Salvador, BA, Brazil, 41120-700
Sponsors and Collaborators
Federal University of Bahia
Investigators
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Principal Investigator: Márcia M Carneiro Oliveira
More Information
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Responsible Party: Márcia Maria Carneiro Oliveira, ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE, Federal University of Bahia
ClinicalTrials.gov Identifier: NCT02230150    
Other Study ID Numbers: ADhesion-HF
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: August 2014
Keywords provided by Márcia Maria Carneiro Oliveira, Federal University of Bahia:
Adhesion, Knowledge, Nursing
Additional relevant MeSH terms:
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Heart Failure
Tissue Adhesions
Heart Diseases
Cardiovascular Diseases
 Cicatrix
Fibrosis
Pathologic Processes