Malnutrition Clinical Characteristics Validation Study

NCT ID: NCT02182427

Last Updated: 2016-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-10-31

Brief Summary

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Malnutrition (under-nutrition) occurs in approximately 30% of hospitalized adults worldwide and results in poor outcomes. However there is no universal method for diagnosing malnutrition. A group of experts created a set of 6 characteristics to identify malnutrition. The goal of this project is to determine whether these characteristics are the best indicators to identify malnutrition or if there are other factors that may better identify malnutrition. Because there is no gold standard definition for malnutrition, the investigators will compare the characteristics against outcomes such as length of stay, hospital readmission and death. Outcomes are also influenced by disease state, therefore, information on what brought the patient to the hospital and what happened to them in the hospital will be collected that allows the investigators to separate the effect of malnutrition from disease. The hypothesis for this study is that the malnutrition clinical characteristics and diagnosis criteria, as presented by the experts, are valid and reliable principles for the diagnosis of adult under-nutrition.

Detailed Description

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Conditions

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Malnutrition

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient on inpatient dietitian consult list
* Able to speak English to answer questions
* Ability to provide informed consent (or provided by family member)
* Expected remaining admission time \> 24 hours (determined by no mention of pending discharge in physicians notes)
* Age ≥ 18 years

Exclusion Criteria

* Seen previously by Registered Dietitian during current admission
* Patient on hospice or palliative care, in a psychiatric, maternity, pediatric or day surgery area, or in dedicated trauma or burn unit.
* Life expectancy \<7 days per physician note or Registered Dietitian (RD) judgment
* Participated in the study during a previous admission
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Society for Parenteral and Enteral Nutrition

OTHER

Sponsor Role collaborator

Academy of Nutrition and Dietetics

OTHER

Sponsor Role lead

Responsible Party

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Alison Steiber

Chief Science Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alison Steiber

Role: PRINCIPAL_INVESTIGATOR

Academy of Nutrition and Dietetics

Maree Ferguson

Role: STUDY_CHAIR

Princess Alexandra Hospital

Locations

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University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

St. John's West Shore Hospital

Westlake, Ohio, United States

Site Status

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Site Status

Countries

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United States Australia

References

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White JV, Guenter P, Jensen G, Malone A, Schofield M; Academy of Nutrition and Dietetics Malnutrition Work Group; A.S.P.E.N. Malnutrition Task Force; A.S.P.E.N. Board of Directors. Consensus statement of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition: characteristics recommended for the identification and documentation of adult malnutrition (undernutrition). J Acad Nutr Diet. 2012 May;112(5):730-8. doi: 10.1016/j.jand.2012.03.012. Epub 2012 Apr 25.

Reference Type BACKGROUND
PMID: 22709779 (View on PubMed)

Other Identifiers

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2014-Pilot

Identifier Type: -

Identifier Source: org_study_id

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