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

June 12, 2018 updated by: Rennes University Hospital
The main objective is to evaluate the sensitivity of the EPA® for screening for malnutrition in general medicine in adults.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

563

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Acigné, France, 35690
        • Cabinet médical des Rosiers
      • Berné, France, 56240
        • Cabinet médical des Docteurs Le Vagueres et Godard,
      • Languidic, France, 56440
        • Cabinet médical du Dr Berthier,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients consulting a general practioner in his activity of substitute doctor,

Description

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, ...

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Ronan PhD Thibault, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2018

Primary Completion (Actual)

April 13, 2018

Study Completion (Actual)

April 13, 2018

Study Registration Dates

First Submitted

June 1, 2018

First Submitted That Met QC Criteria

June 12, 2018

First Posted (Actual)

June 13, 2018

Study Record Updates

Last Update Posted (Actual)

June 13, 2018

Last Update Submitted That Met QC Criteria

June 12, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC17_3087-GEN-EPA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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