NCT03555461

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
563

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
Last Updated

June 13, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

June 1, 2018

Last Update Submit

June 12, 2018

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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, ...

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cabinet médical des Rosiers

Acigné, 35690, France

Location

Cabinet médical des Docteurs Le Vagueres et Godard,

Berné, 56240, France

Location

Cabinet médical du Dr Berthier,

Languidic, 56440, France

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Ronan PhD Thibault

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2018

First Posted

June 13, 2018

Study Start

January 22, 2018

Primary Completion

April 13, 2018

Study Completion

April 13, 2018

Last Updated

June 13, 2018

Record last verified: 2018-05

Locations

FR(3)