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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03588169
Other study ID # BRINDISI 2018 CNO_ALIMS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 14, 2019
Est. completion date February 28, 2019

Study information

Verified date October 2019
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Over 30% of hospitalized patients are malnourished. These figures range from 20% to 60% in geriatric units. Undernutrition results either from a decrease in energy intake, an increase in needs, an increase in losses or a combination of these three causes. As a factor in mortality, morbidity and lengthening the time of hospital stays, undernutrition induces health costs 45 to 102% higher than a person who is not undernourished. The nutritional management of patients initially includes hygieno-dietary advice, then the implementation of an oral nutritional supplementation (ONS). A recent study conducted by our teams highlighted the low ONS consumption among women compared to men (39.48% vs 73.41%). Interviews with patients showed that 13 out of 17 had a negative opinion of ONS.

The aim of this study is to show, on a larger scale, whether ONS consumption differs according to sex and if so, to highlight the obstacles to this consumption through the implementation of semi-directive interviews with patients. Ultimately, this research will lead to the implementation of alternative strategies to improve ONS consumption and to a better understanding of the obstacles to ONS consumption.


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date February 28, 2019
Est. primary completion date February 28, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patient who has given oral consent

- over 18 years

- orally fed

- with a prescription for ONS

- speaks and understands French

- hospital stay longer than 4 days

Exclusion Criteria:

- adult under tutelage

- pregnant or breastfeeding women

- cognitive disorders

- patient does not speak or understand French

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
semi-structured interviews
About 30 minutes and touching on the following subjects: perception of hospital meals patient representation of ONS taking ONS and feelings about it

Locations

Country Name City State
France Chu Dijon Bourogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Semi-structured individual interviews 1 day on inclusion
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