NCT02913846

Brief Summary

Denutrition is defined as a measurable decrease in functions and/or as change in the body composition, associated with a worsening of the prognosis of the underlying medico-surgical pathology. It is induced by a deficiency in energy, proteins or any other micro or macronutrient and is the result of malnutrition, itself caused by a poor diet or a metabolic disorder. According to the National Nutrition and Health Plan for Belgium, denutrition is an independent risk factor for the increase of complications, morbidity and mortality rates, average length of hospitalisation and global medical care cost. It is necessary to invest in the prevention of denutrition as the costs of preventive measures are lower than the cost of treating a denutrished patient. The Belgian financing system of hospitalisation days is based on the structure of the treated pathologies, the age of the patient and the geriatric features of the patient. It encourages all hospitals to lower the length of hospitalisation to the national average for all these criteria. As a consequence, there is a mounting tendency to shorten the average length of stay within the hospital. The so-called 'Sp' hospital departments occupy a specific place within the organisation of Health Services in Belgium. They are specialized in the treatment and rehabilitation of patients with cardiopulmonary, neurological, locomotor, psycho-geriatric and chronic diseases. These services act as an extension of acute services (continuity of acute hospitalisation) but also as a first entry point for the medical care of patients with various specific diseases (multiple sclerosis, psycho-geriatric disorders, chronic pulmonary disorders...). The financing of the Sp departments is, as opposed to the financing of other departments, not linked to the patient length of stay. However, an increase in hospitalization duration decreases the rate of admissions and the possibility to accept patients coming from acute hospital units. The aim of the study is to evaluate the influence of denutrition of patients hospitalized in an Sp department on the length of revalidation stay, the associated costs and the patient's functional autonomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

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

Study Start

First participant enrolled

March 18, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2017

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

1.5 years

First QC Date

September 14, 2016

Last Update Submit

January 18, 2018

Conditions

Keywords

denutritionhospital length of staypatient's autonomy

Outcome Measures

Primary Outcomes (6)

  • Barthel index score

    Assessment of patient autonomy

    within 48h of admission within the revalidation unit

  • Nutritional Risk Screening score

    Nutritional state assessment

    within 48h of admission within the revalidation unit

  • Body Mass Index

    once a week up to patient discharge (the average hospitalization length within the revalidation unit is 48 days)

  • Weight

    once a week up to patient discharge (the average hospitalization length within the revalidation unit is 48 days)

  • Hand prehension force

    performed on the right hand with a Jamart dynamometer

    once a week up to patient discharge (the average hospitalization length within the revalidation unit is 48 days)

  • Pre-albumine level (mg/l)

    Laboratory testing

    once a week up to patient discharge (the average hospitalization length within the revalidation unit is 48 days)

Study Arms (1)

Hospital revalidation units

The study will take place within the CHU Brugmann hospital (Brussels) who has 4 revalidation units (104 beds). All patients coming within these units during the study duration will be included.

Other: Nutritional evaluationOther: Muscular assessmentOther: Pre-albumine dosage

Interventions

A first nutritional evaluation will be performed within 48h of patient admission. Weight and BMI will be measured once a week.

Hospital revalidation units

An assessment of muscular force will be performed once a week.

Hospital revalidation units

Dosage performed once a month.

Hospital revalidation units

Eligibility Criteria

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

All patients admitted within a revalidation unit of the CHU Brugmann hospital

You may qualify if:

  • All patients admitted within a revalidation unit of the CHU Brugmann hospital

You may not qualify if:

  • Patients without programmed exit: transfer to another care unit, forced exit, death...

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (1)

  • Alvarez-Hernandez J, Planas Vila M, Leon-Sanz M, Garcia de Lorenzo A, Celaya-Perez S, Garcia-Lorda P, Araujo K, Sarto Guerri B; PREDyCES researchers. Prevalence and costs of malnutrition in hospitalized patients; the PREDyCES Study. Nutr Hosp. 2012 Jul-Aug;27(4):1049-59. doi: 10.3305/nh.2012.27.4.5986.

    PMID: 23165541BACKGROUND

Study Officials

  • Samar Hatem, MD

    CHU Brugmann

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

September 14, 2016

First Posted

September 26, 2016

Study Start

March 18, 2016

Primary Completion

September 12, 2017

Study Completion

September 12, 2017

Last Updated

January 23, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations