NCT00673530

Brief Summary

The purpose of this study is to determine whether there is a positive correlation between an evidence based clinical nutrition concept and relevant clinical outcomes in malnourished hospitalised patients when severity of disease is adjusted.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10,242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2006

Geographic Reach
1 country

4 active sites

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

Study Start

First participant enrolled

July 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
Last Updated

March 8, 2016

Status Verified

February 1, 2009

Enrollment Period

1.4 years

First QC Date

May 1, 2008

Last Update Submit

March 7, 2016

Conditions

Malnutrition

Keywords

Hospital malnutritionNutritional StatusNutrition AssessmentEnteral NutritionParenteral NutritionSeverity of illness indexcost analysis

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    At least 3 months each group, 6 months for both groups

Secondary Outcomes (4)

  • all cause hospital mortality

    At least 3 months each group, 6 months for both groups

  • complication rate

    At least 3 months each group, 6 months for both groups

  • hospital readmission rate

    1 Month each group

  • Economic devices (direct costs of inpatient care and reimbursement)

    At least 4 months each group, 7 months for both groups

Study Arms (2)

1

EXPERIMENTAL

evidence based clinical nutrition concept

Behavioral: evidence based clinical nutrition concept

2

OTHER

care as usual

Behavioral: care as usual

Interventions

evidence based clinical nutrition conceptBEHAVIORAL

The evidence based nutrition concept comprise a routine malnutrition screening for hospitalized patients, the implementation of an evidence based guideline for clinical nutrition in the participating hospital, education training of the clinical staff and thereby optimal clinical nutrition for malnourished hospitalized patients.

Also known as: Optimized clinical nutrition concept
1
care as usualBEHAVIORAL

Unchanged treatment of hospital patients without interference by the study.

2

Eligibility Criteria

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

You may qualify if:

  • at least 18 years of age
  • internal or operative admission diagnosis in participating hospitals

You may not qualify if:

  • Patients with demand for emergency care
  • Patients with demand for intensive care
  • Patients with hospital day-care
  • Patients unwilling to participate or unable to comply with the protocol in the control group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Städtisches Klinikum Ansbach

Ansbach, Germany

Location

Kliniken Südliche Weinstraße Landau

Bad Bergzaben, Germany

Location

Evangelische und Johanniter Kliniken

Duisburg, Germany

Location

Kreiskrankenhaus Hameln

Hamelin, Germany

Location

MeSH Terms

Conditions

MalnutritionHyperphagia

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan N Willich, Prof. Dr.

    Charite University, Berlin, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 1, 2008

First Posted

May 7, 2008

Study Start

July 1, 2006

Primary Completion

December 1, 2007

Study Completion

March 1, 2008

Last Updated

March 8, 2016

Record last verified: 2009-02

Locations

DE(4)