Analysis of EPA® (a Food Intake Assessment Tool) as a Scr... | NCT03555461

Studies
Analysis of EPA® (a Food Intake Assessment Tool) as a Screening Test for Malnutrition in General Medicine

NCT03555461

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Jun 13, 2018Actual

Enrollment

563Actual

Phase

Not provided

Conditions

Malnutrition

Interventions

Not provided

Countries

France

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

May 2018

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

Jan 22, 2018Actual

Primary Completion Date

Apr 13, 2018Actual

Completion Date

Apr 13, 2018Actual

First Submitted Date

Jun 1, 2018

First Submission Date that Met QC Criteria

Jun 12, 2018

First Posted Date

Jun 13, 2018Actual

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

Jun 12, 2018

Last Update Posted Date

Jun 13, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

563Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
presence or absence of malnutrition	presence or absence of malnutrition based on BMI and / or percentage of weight loss	The inclusion day
Score EPA	score obtained with the EPA® tool (assessment of food intake)	The inclusion day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

To be an adult,
Consulting the principal investigator, a general practitioner in his activity of substitute doctor,
During the inclusion period,
Not opposed to participating in the study.

Exclusion Criteria:

Patients benefiting from artificial nutrition,
Patients with advanced dementia,
Pregnant or postpartum women,
Patients who do not understand or speak French,
Patients treated with diuretics who have had a change in treatment dosage during the last 6 months,
Patients for whom weight measurement is not possible in the office (wheelchair, disability ...),
Patients who have already been included once,
Patients who have had surgery for obesity,
Major persons subject to legal protection (legal safeguards, guardianship, tutorship), persons deprived of their liberty, ...

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 consulting a general practioner in his activity of substitute doctor,

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ronan PhD Thibault	Rennes University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cabinet médical des Rosiers		Acigné		35690	France
Cabinet médical des Docteurs Le Vagueres et Godard,

Condition Browse Module

MeSH Terms

ID	Term
D044342	Malnutrition

Ancestor Terms

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided