MalnutritionNUTRICORENCT00673530
Clinical Nutrition Concept for Hospitalized Patients With Malnutrition
A study testing evidence based clinical nutrition concept and care as usual in people with Malnutrition, run by Charite University, Berlin, Germany at 4 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- evidence based clinical nutrition concept and care as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,242 participants
- Where
- 4 sitesGermany
- Study dates
- Jul 2006to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- internal or operative admission diagnosis in participating hospitals
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Städtisches Klinikum Ansbach
Ansbach
Kliniken Südliche Weinstraße Landau
Bad Bergzaben
Evangelische und Johanniter Kliniken
Duisburg
Kreiskrankenhaus Hameln
Hamelin
About this study
Official title: Effect of an Evidence Based Clinical Nutrition Concept on Clinical Outcomes in Hospitalized Patients With Malnutrition When Severity of Disease is Taken Into Consideration
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.
Read the detailed description
Patients have been consecutively screened at admission by SGA (Subjective-Global-Assessment)-Score and NRS 2002 (Nutritional-Risk-Screening)-Score in the departments of surgery and internal medicine. The nutrition status of each patient is combined with clinical data, utilization data and direct costs on the basis of clinical homogenous patient clusters. Risk-Adjustment was provided by the Disease-Staging-Scale (MEDSTAT/Thomson Healthcare, Ann Arbor MI), which allows patient classification by diagnosis and co morbidities including age and gender. The risk adjustment scales run by routine data sets from german inpatient G-DRG system. In the control period the effects of usual nutrition care are documented. During the intervention period an implementation of an interdisciplinary evidence-based guideline for screening and clinical nutrition was introduced in each participating hospital.
The issue is to describe the relation between risk-adjusted malnutrition status and clinical outcomes and costs.
- Conditions
- Malnutrition
- Being tested
- evidence based clinical nutrition concept, care as usual
- Keywords
- Hospital malnutrition, Nutritional Status, Nutrition Assessment, Enteral Nutrition, Parenteral Nutrition, Severity of illness index, cost analysis
- Medical subject headings
- Malnutrition, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evidence based clinical nutrition conceptBehavioural
Also called Optimized clinical nutrition concept
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.
care as usualBehavioural
Unchanged treatment of hospital patients without interference by the study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | evidence based clinical nutrition concept Receives: Behavioral: evidence based clinical nutrition concept |
| 2 | Other | care as usual Receives: Behavioral: care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Measured: At least 3 months each group, 6 months for both groups
Secondary outcomes (4)
all cause hospital mortality
Measured: At least 3 months each group, 6 months for both groups
complication rate
Measured: At least 3 months each group, 6 months for both groups
hospital readmission rate
Measured: 1 Month each group
Economic devices (direct costs of inpatient care and reimbursement)
Measured: At least 4 months each group, 7 months for both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startJul 2006
- Primary completionDec 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Stefan N Willich, Prof. Dr., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673530
- Sponsor's protocol ID
- NUTRICORE
- Acronym
- NUTRICORE
- Status last verified
- Feb 2009
- First submitted
- 1 May 2008
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Evidence Based Clinical Nutrition Concept on Clinical Outcomes in Hospitalized Patients With Malnutrition When Severity of Disease is Taken Into Consideration
- ClinicalTrials.gov ID
- NCT00673530
- Acronym / sponsor ID
- NUTRICORE / NUTRICORE
- Conditions
- Malnutrition
- Keywords
- Hospital malnutrition, Nutritional Status, Nutrition Assessment, Enteral Nutrition, Parenteral Nutrition, Severity of illness index, cost analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,242 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients have been consecutively screened at admission by SGA (Subjective-Global-Assessment)-Score and NRS 2002 (Nutritional-Risk-Screening)-Score in the departments of surgery and internal medicine. The nutrition status of each patient is combined with clinical data, utilization data and direct costs on the basis of clinical homogenous patient clusters. Risk-Adjustment was provided by the Disease-Staging-Scale (MEDSTAT/Thomson Healthcare, Ann Arbor MI), which allows patient classification by diagnosis and co morbidities including age and gender. The risk adjustment scales run by routine data sets from german inpatient G-DRG system. In the control period the effects of usual nutrition care are documented. During the intervention period an implementation of an interdisciplinary evidence-based guideline for screening and clinical nutrition was introduced in each participating hospital.
The issue is to describe the relation between risk-adjusted malnutrition status and clinical outcomes and costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: evidence based clinical nutrition conceptevidence based clinical nutrition concept |
| 2 | Other | Behavioral: care as usualcare as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 18 years of age
- internal or operative admission diagnosis in participating hospitals
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evidence based clinical nutrition conceptAlso: Optimized clinical nutrition conceptThe 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. | Behavioural | 1 |
| care as usualUnchanged treatment of hospital patients without interference by the study. | Behavioural | 2 |
Primary outcome
Length of hospital stay
Time frame: At least 3 months each group, 6 months for both groups
4 secondary outcomes
all cause hospital mortality
Time frame: At least 3 months each group, 6 months for both groups
complication rate
Time frame: At least 3 months each group, 6 months for both groups
hospital readmission rate
Time frame: 1 Month each group
Economic devices (direct costs of inpatient care and reimbursement)
Time frame: At least 4 months each group, 7 months for both groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan N Willich, Prof. Dr. study director
Charite University, Berlin, Germany
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing evidence based clinical nutrition concept and care as usual in people with Malnutrition, run by Charite University, Berlin, Germany at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: At least 3 months each group, 6 months for both groups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.