Simplified Nutritional Screening for Patient Use | NCT00714324

Studies
Simplified Nutritional Screening for Patient Use

NCT00714324

Sponsor

University of Southampton

Status

Unknown status

Last Update Posted

Jan 5, 2009Estimated

Enrollment

2,200Estimated

Phase

Not provided

Conditions

Malnutrition

Interventions

Not provided

Countries

United Kingdom

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 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jul 2009Estimated

Completion Date

Jul 2009Estimated

First Submitted Date

Jul 3, 2008

First Submission Date that Met QC Criteria

Jul 11, 2008

First Posted Date

Jul 14, 2008Estimated

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 2, 2009

Last Update Posted Date

Jan 5, 2009Estimated

Name	Class
University Hospital Southampton NHS Foundation Trust	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

The purpose of this study is to determine if patients are able to reliably screen themselves for nutrition risk.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

2,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Paper screening
2		Electronic screening

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To validate the use of a screening tool for patient use		1 year

Secondary Outcomes

Measure	Description	Time Frame
To assess prevalence of malnutrition in outpatients		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female
Adults aged > 18years
Able to complete screening and provide written informed consent
Willingness to take part

Exclusion Criteria:

Children (<18years)
Pregnant women
Inpatients
Unable to complete screen due to physical or mental incapacity
Unable to comprehend oral and written English language
Participation in other nutrition studies

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

Patients attending general outpatient clinics

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marinos Elia, Professor	Contact	02380 796317		elia@soton.ac.uk

Overall Officials

Name	Affiliation	Role
Marinos Elia, Professor	University of Southampton	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southampton University Hospitals NHS trust	Recruiting	Southampton	Hampshire	SO16 6YD	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23034963	Derived	Cawood AL, Elia M, Sharp SK, Stratton RJ. Malnutrition self-screening by using MUST in hospital outpatients: validity, reliability, and ease of use. Am J Clin Nutr. 2012 Nov;96(5):1000-7. doi: 10.3945/ajcn.112.037853. Epub 2012 Oct 3.

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases