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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
Malnutrition Clinical Characteristics Validation Study
Secondary ID [1] 0 0
2014-Pilot
Universal Trial Number (UTN)
Trial acronym
MCC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants diagnosed with and without malnutrition using the MCC.
Timepoint [1] 0 0
30-days post-discharge
Secondary outcome [1] 0 0
30-day readmission rate among study participants
Timepoint [1] 0 0
Within 90 days after data collection is complete

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Ohio

Funding & Sponsors
Primary sponsor type
Other
Name
Academy of Nutrition and Dietetics
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
American Society for Parenteral and Enteral Nutrition
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02182427
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.
Public notes

Contacts
Principal investigator
Name 0 0
Alison Steiber
Address 0 0
Academy of Nutrition and Dietetics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02182427