MalnutritionGEN-EPANCT03555461
Analysis of EPA® (a Food Intake Assessment Tool) as a Screening Test for Malnutrition in General Medicine
An observational study of Malnutrition, run by Rennes University Hospital at 3 sites in France.
Trial summary
The main objective is to evaluate the sensitivity of the EPA® for screening for malnutrition in general medicine in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- How many people
- 563 participants
- Where
- 3 sitesFrance
- Study dates
- 22 Jan 2018to 13 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients consulting a general practioner in his activity of substitute doctor,
Who may be able to join
- 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.
Who cannot join
- 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 ...),
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- 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, ...
Trial locations and contacts
3 sites in 1 country.
France3 sites
Cabinet médical des Rosiers
Acigné, 35690
Cabinet médical des Docteurs Le Vagueres et Godard,
Berné, 56240
Cabinet médical du Dr Berthier,
Languidic, 56440
About this study
The main objective is to evaluate the sensitivity of the EPA® for screening for malnutrition in general medicine in adults.
- Conditions
- Malnutrition
- Medical subject headings
- Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
presence or absence of malnutrition
presence or absence of malnutrition based on BMI and / or percentage of weight loss
Measured: The inclusion day
Score EPA
score obtained with the EPA® tool (assessment of food intake)
Measured: The inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start22 Jan 2018
- Primary completion13 Apr 2018
- Study completion13 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronan PhD Thibault, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555461
- Sponsor's protocol ID
- 35RC17_3087-GEN-EPA
- Acronym
- GEN-EPA
- Status last verified
- May 2018
- First submitted
- 1 Jun 2018
- Last updated
- 13 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of EPA® (a Food Intake Assessment Tool) as a Screening Test for Malnutrition in General Medicine
- ClinicalTrials.gov ID
- NCT03555461
- Acronym / sponsor ID
- GEN-EPA / 35RC17_3087-GEN-EPA
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 13 Apr 2018 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to evaluate the sensitivity of the EPA® for screening for malnutrition in general medicine in adults.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consulting a general practioner in his activity of substitute doctor,
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
presence or absence of malnutrition
Time frame: The inclusion day
presence or absence of malnutrition based on BMI and / or percentage of weight loss
Score EPA
Time frame: The inclusion day
score obtained with the EPA® tool (assessment of food intake)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronan PhD Thibault principal investigator
Rennes University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Rennes University Hospital at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence or absence of malnutrition (time frame: The inclusion day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2018.