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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02182427
Registration number
NCT02182427
Ethics application status
Date submitted
1/07/2014
Date registered
8/07/2014
Date last updated
27/01/2016
Titles & IDs
Public title
Malnutrition Clinical Characteristics Validation Study
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Scientific title
Malnutrition Clinical Characteristics Validation Study
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Secondary ID [1]
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2014-Pilot
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Universal Trial Number (UTN)
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Trial acronym
MCC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malnutrition
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Condition category
Condition code
Diet and Nutrition
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants diagnosed with and without malnutrition using the MCC.
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Assessment method [1]
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Timepoint [1]
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30-days post-discharge
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Secondary outcome [1]
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30-day readmission rate among study participants
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Assessment method [1]
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Timepoint [1]
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Within 90 days after data collection is complete
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2015
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Sample size
Target
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Accrual to date
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Final
54
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Princess Alexandra Hospital - Brisbane
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Recruitment postcode(s) [1]
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4102 - Brisbane
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Ohio
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Funding & Sponsors
Primary sponsor type
Other
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Name
Academy of Nutrition and Dietetics
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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American Society for Parenteral and Enteral Nutrition
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02182427
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Trial related presentations / publications
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. Erratum In: J Acad Nutr Diet. 2012 Nov;112(11):1899. J Acad Nutr Diet. 2017 Mar;117(3):480. doi: 10.1016/j.jand.2017.01.021.
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Public notes
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Contacts
Principal investigator
Name
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Alison Steiber
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Address
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Academy of Nutrition and Dietetics
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02182427
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