NCT03588169

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 4, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

January 14, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

October 16, 2019

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

July 4, 2018

Last Update Submit

October 15, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Semi-structured individual interviews

    1 day on inclusion

Study Arms (1)

patients hospitalized at the Dijon University Hospital

Patients hospitalized in the endocrinology, digestive surgery, pneumology and geriatric units of the Dijon University Hospital with a prescription for ONS

Dietary Supplement: semi-structured interviews

Interventions

semi-structured interviewsDIETARY_SUPPLEMENT

About 30 minutes and touching on the following subjects: * perception of hospital meals * patient representation of ONS * taking ONS and feelings about it

patients hospitalized at the Dijon University Hospital

Eligibility Criteria

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

Patients hospitalised in the endocrinology, digestive surgery, pneumology and geriatrics departments of the Dijon University Hospital, with a prescription for ONS

You may qualify if:

  • 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

You may not qualify if:

  • adult under tutelage
  • pregnant or breastfeeding women
  • cognitive disorders
  • patient does not speak or understand French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

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

Study Record Dates

First Submitted

July 4, 2018

First Posted

July 17, 2018

Study Start

January 14, 2019

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

October 16, 2019

Record last verified: 2019-10

Locations