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

Heart Failure Clinical Trial

— ADhesion-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230150
• Other study ID #: ADhesion-HF
• Status: Completed
• Phase: N/A
• First received: August 20, 2014
• Last updated: August 29, 2014
• Start date: December 2012
• Est. completion date: April 2013

Study information

• Verified date: August 2014
• Source: Federal University of Bahia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Failure
• Tissue Adhesions

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Ana Nery	Salvador	BA

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	performance in the six minutes walk test	monitor the difference in performance of the 6-minute walk test in adherent and non-adherent	1 month	Yes
Primary	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.	1 month	Yes
Secondary	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	1 month	Yes