NCT02230150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed
Last Updated

September 3, 2014

Status Verified

August 1, 2014

Enrollment Period

4 months

First QC Date

August 20, 2014

Last Update Submit

August 29, 2014

Conditions

Keywords

Adhesion, Knowledge, Nursing

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • changes in biomarkers: Nt-proBNP, sodium, potassium, urea and creatinine

    1 month

Other Outcomes (1)

  • performance in the six minutes walk test

    1 month

Interventions

Adhesion-HFBEHAVIORAL

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Ana Nery

Salvador, Estado de Bahia, 41120-700, Brazil

Location

MeSH Terms

Conditions

Heart FailureTissue Adhesions

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Márcia M Carneiro Oliveira

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE

Study Record Dates

First Submitted

August 20, 2014

First Posted

September 3, 2014

Study Start

December 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

September 3, 2014

Record last verified: 2014-08

Locations