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

Status

Completed

Conditions

Intervention / Treatment

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 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

  • Brazil
    • BA
      • Salvador, BA, Brazil, 41120-700
        • Hospital Ana Nery

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

Federal University of Bahia

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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