Malnutrition Clinical Characteristics Validation Study | NCT02182427

Studies
Malnutrition Clinical Characteristics Validation Study

NCT02182427

Sponsor

Academy of Nutrition and Dietetics

Status

Completed

Last Update Posted

Jan 27, 2016Estimated

Enrollment

54Actual

Phase

Not provided

Conditions

Malnutrition

Interventions

Not provided

Countries

United States
Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Jul 1, 2014

First Submission Date that Met QC Criteria

Jul 2, 2014

First Posted Date

Jul 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2016

Last Update Posted Date

Jan 27, 2016Estimated

Name	Class
American Society for Parenteral and Enteral Nutrition	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants diagnosed with and without malnutrition using the MCC.		30-days post-discharge

Secondary Outcomes

Measure	Description	Time Frame
30-day readmission rate among study participants		Within 90 days after data collection is complete

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All eligible patients (according to the inclusion and exclusion criteria seen below) who are admitted to one of the following acute care facilities: University Hospitals Case Medical Center, Cleveland Clinic, and St. John's Westshore in Cleveland, Ohio, United States, and Princess Alexandra Hospital in Brisbane, Queensland, Australia.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alison Steiber	Academy of Nutrition and Dietetics	Principal Investigator
Maree Ferguson	Princess Alexandra Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals Case Medical Center		Cleveland	Ohio	44106	United States
Cleveland Clinic

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22709779	Background	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.

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases