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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03555461
Other study ID # 35RC17_3087-GEN-EPA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 22, 2018
Est. completion date April 13, 2018

Study information

Verified date May 2018
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main objective is to evaluate the sensitivity of the EPA® for screening for malnutrition in general medicine in adults.


Recruitment information / eligibility

Status Completed
Enrollment 563
Est. completion date April 13, 2018
Est. primary completion date April 13, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Cabinet médical des Rosiers Acigné
France Cabinet médical des Docteurs Le Vagueres et Godard, Berné
France Cabinet médical du Dr Berthier, Languidic

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

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