NCT00957814

Brief Summary

The nutritional systematic orientations in outpatients with heart failure throughout 1 year in comparison to conventional treatment is estimated to lead to higher nutritional treatment adherence and improved nutritional status, clinical and life quality parameters.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2009

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

August 11, 2009

Last Update Submit

October 25, 2016

Conditions

NutritionHeart Failure

Keywords

nutritional educationdiet adherencenutritional knowledgelife qualitynutritional statusimpact of nutritional orientations by a systematic education program applied to outpatients with HF, in comparison to patients in a conventional treatment.

Outcome Measures

Primary Outcomes (1)

  • Diet adherence

    1 year

Secondary Outcomes (1)

  • Knowledge about nutrition, nutritional status, biochemical parameters and life quality

    1 year

Study Arms (2)

Control

EXPERIMENTAL

Usual care with medical and nursing staff

Behavioral: Nutritional education

Intervention

EXPERIMENTAL

Usual care with medical and nursing staff and additional nutritional guidance about diet and its relationship with disease, sources of nutrients, and reduction of dietary sodium and fats. Enforcement of the nutritional guidance was performed after 4 weeks.

Behavioral: Nutritional education

Interventions

Nutritional educationBEHAVIORAL

Systematic nutritional orientation program

ControlIntervention

Eligibility Criteria

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

You may qualify if:

  • \>= 18 years old
  • Outpatients from the HF Ambulatory (HCPA)
  • Functional class I and II (NYHA)

You may not qualify if:

  • Outpatient who had received any orientation from a nutritionist in the last 6 months
  • Outpatients which has not received nursing orientation in the ambulatory,
  • Patients from other NYHA class
  • Non alphabetized

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 11, 2009

First Posted

August 12, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2010

Study Completion

November 1, 2010

Last Updated

October 27, 2016

Record last verified: 2016-10