<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02230150</url>
  </required_header>
  <id_info>
    <org_study_id>ADhesion-HF</org_study_id>
    <nct_id>NCT02230150</nct_id>
  </id_info>
  <brief_title>ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE - ADhesion-HF</brief_title>
  <acronym>ADhesion-HF</acronym>
  <official_title>ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE - ADhesion-HF</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Bahia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Bahia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to verify the impact of the educational intervention in the&#xD;
      adhesion to therapeutic strategies for patients with heart failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Characterize the socio-demographic and clinical aspects of heart failure patients;&#xD;
&#xD;
        2. Awareness before and after nursing consultation, in relation to diet for heart failure,&#xD;
           liquid and weight, general heart failure information, medication, physical activity,&#xD;
           measures to improve disease control, signs of decompensated heart failure;&#xD;
&#xD;
        3. Adhesion of patients before and after nursing consultation, related to medication,&#xD;
           liquid and weight, use of alcohol and importance of returning for consultation and&#xD;
           exams.&#xD;
&#xD;
        4. Evaluated the impact of educational intervention at the levels of NT-proBNP, urea,&#xD;
           creatinine, sodium, potassium, before and after nursing consultation;&#xD;
&#xD;
        5. The 6 minute walk test performance before and after nursing consultation;&#xD;
&#xD;
        6. The distance covered and time of the 6 minute walk test, until fatigue in heart failure&#xD;
           patients before and after nursing consultation;&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE</measure>
    <time_frame>1 month</time_frame>
    <description>Verify the impact of the educational intervention in the adhesion to therapeutic strategies for patients with heart failure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in biomarkers: Nt-proBNP, sodium, potassium, urea and creatinine</measure>
    <time_frame>1 month</time_frame>
    <description>changes in biomarkers: Nt-proBNP, sodium, potassium, urea and creatinine before and after nursing consultation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>performance in the six minutes walk test</measure>
    <time_frame>1 month</time_frame>
    <description>monitor the difference in performance of the 6-minute walk test in adherent and non-adherent</description>
  </other_outcome>
  <enrollment type="Actual">25</enrollment>
  <condition>Heart Failure</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Adhesion-HF</intervention_name>
    <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.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  During the first phase of the study all the heart failure patients with ventricular&#xD;
             ejection fraction of up to 49% shall be included (confirmed through ECOTT performed&#xD;
             during the past year). All patients inserted had systolic heart failure and were&#xD;
             scheduled and which agreed to take part of the research, signing a term of informed&#xD;
             consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with cognitive deficit, first outpatient medical consultation, suffered&#xD;
             AMI (acute myocardial infarction) within the last 3 months or a stroke, post-operative&#xD;
             of cardiac surgery, patients with chronic obstructive pulmonary disease (COPD),&#xD;
             orthopedic problems, patients over the age of 80 and those that do not accept to&#xD;
             participate of the research.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Márcia M Carneiro Oliveira</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Ana Nery</name>
      <address>
        <city>Salvador</city>
        <state>BA</state>
        <zip>41120-700</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>August 29, 2014</last_update_submitted>
  <last_update_submitted_qc>August 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Bahia</investigator_affiliation>
    <investigator_full_name>Márcia Maria Carneiro Oliveira</investigator_full_name>
    <investigator_title>ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE</investigator_title>
  </responsible_party>
  <keyword>Adhesion, Knowledge, Nursing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Tissue Adhesions</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02230150
org study id: ADhesion-HF
nct id: NCT02230150
lead sponsor: 
has dmc: No
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.
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;
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE
time frame: 1 month
description: Verify the impact of the educational intervention in the adhesion to therapeutic strategies for patients with heart failure.
measure: changes in biomarkers: Nt-proBNP, sodium, potassium, urea and creatinine
time frame: 1 month
description: changes in biomarkers: Nt-proBNP, sodium, potassium, urea and creatinine before and after nursing consultation
measure: performance in the six minutes walk test
time frame: 1 month
description: monitor the difference in performance of the 6-minute walk test in adherent and non-adherent
intervention type: Behavioral
intervention name: Adhesion-HF
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.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Márcia M Carneiro Oliveira
role: Principal Investigator
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Bahia
investigator full name: Márcia Maria Carneiro Oliveira
investigator title: ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE
mesh term: Heart Failure
mesh term: Tissue Adhesions