History of Changes for Study: NCT02913846

The Impact of Denutrition on the Hospital Length of Stay for Patients Undergoing Rehabilitation

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			September 22, 2016	None (earliest Version on record)
2			January 18, 2018	Recruitment Status, Study Status, Contacts/Locations, Oversight and Study Design

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Study Identification


Unique Protocol ID:	CHUB-Nut-Reva
Brief Title:	The Impact of Denutrition on the Hospital Length of Stay for Patients Undergoing Rehabilitation
Official Title:	The Impact of Denutrition on the Hospital Length of Stay for Patients Undergoing Rehabilitation
Secondary IDs:

Study Status


Record Verification:	September 2016
Overall Status:	Recruiting
Study Start:	September 2016
Primary Completion:	December 2016 [Anticipated]
Study Completion:	December 2016 [Anticipated]

First Submitted:	September 14, 2016
First Submitted that Met QC Criteria:	September 22, 2016
First Posted:	September 26, 2016 [Estimate]

Last Update Submitted that Met QC Criteria:	September 22, 2016
Last Update Posted:	September 26, 2016 [Estimate]

Sponsor/Collaborators


Sponsor:	Brugmann University Hospital
Responsible Party:	Principal Investigator Investigator: Samar Hatem Official Title: Head of clinic Affiliation: Brugmann University Hospital
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	No

Study Description

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.

Detailed Description:

Conditions


Conditions:	Denutrition
Keywords:	denutrition hospital length of stay patient's autonomy

Study Design


Study Type:	Observational
Observational Study Model:	Cohort
Time Perspective:	Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	180 [Anticipated]
Number of Groups/Cohorts	1

Groups and Interventions

Groups/Cohorts	Interventions
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.	Nutritional evaluation A first nutritional evaluation will be performed within 48h of patient admission. Weight and BMI will be measured once a week. Muscular assessment An assessment of muscular force will be performed once a week. Pre-albumine dosage Dosage performed once a month.

Outcome Measures


Primary Outcome Measures:
1.	Barthel index score [ Time Frame: within 48h of admission within the revalidation unit ] Assessment of patient autonomy
2.	Nutritional Risk Screening score [ Time Frame: within 48h of admission within the revalidation unit ] Nutritional state assessment
3.	Body Mass Index [ Time Frame: once a week up to patient discharge (the average hospitalization length within the revalidation unit is 48 days) ]
4.	Weight [ Time Frame: once a week up to patient discharge (the average hospitalization length within the revalidation unit is 48 days) ]
5.	Hand prehension force [ Time Frame: once a week up to patient discharge (the average hospitalization length within the revalidation unit is 48 days) ] performed on the right hand with a Jamart dynamometer
6.	Pre-albumine level (mg/l) [ Time Frame: once a week up to patient discharge (the average hospitalization length within the revalidation unit is 48 days) ] Laboratory testing

Eligibility


Study Population:	All patients admitted within a revalidation unit of the CHU Brugmann hospital
Sampling Method:	Probability Sample
Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: All patients admitted within a revalidation unit of the CHU Brugmann hospital Exclusion Criteria: Patients without programmed exit: transfer to another care unit, forced exit, death...

Contacts/Locations


Central Contact Person:	Mafalda Vieira Cunha, Nurse Email: Mafalda.VIEIRACUNHA@chu-brugmann.be
Central Contact Backup:	Samar Hatem, MD Email: Samar.HATEM@chu-brugmann.be
Study Officials:	Samar Hatem, MD Study Director CHU Brugmann
Locations:	Belgium
	CHU Brugmann [Recruiting] Brussels, Belgium, 1020 Contact:Contact: Mafalda VIEIRA CUNHA, Nurse Mafalda.VIEIRACUNHA@chu-brugmann.be Contact:Principal Investigator: Samar Hatem, MD Contact:Sub-Investigator: Mafalda VIEIRA CUNHA, Nurse

IPDSharing


Plan to Share IPD:	No

References


Citations:	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. PubMed 23165541
Links:
Available IPD/Information: