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Evaluation of the SARC-F Score as a Screening Tool for Undernutrition in a Geriatric Population (GERIASARC)

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ClinicalTrials.gov Identifier: NCT03553147
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

To study the relationship between sarcopenia and undernutrition in adult patients over 70 years of age, and at the same time to define a threshold value for the predictive SARC-F score of undernutrition.

Hypothesis : the SARC-F score is correlated with malnutrition defined according to the following HAS criteria :

Moderate denutrition Severe denutrition


Condition or disease Intervention/treatment Phase
Sarcopenia Denutrition Other: SARC-F score, handgrip test and impedancemetry Not Applicable

Detailed Description:

The geriatric population is a population at risk, given the frequent and numerous comorbidities present. Undernutrition is one of these, which is frequently associated with sarcopenia, that is, a decrease in muscle strength. Its screening must be early to avoid complications (osteoporosis, fractures, infections ...) and given the cost it generates for society. However, the detection of undernutrition can sometimes be time-consuming and its criteria in default, such as in the presence of edema or obesity, for example. There is a score, the SARC-F, which allows to detect sarcopenia from a result greater than or equal to 4, but which does not allow direct detection of undernutrition.

The primary objective is to evaluate the SARC-F score as a screening tool for undernutrition in a geriatric population, secondary objectives being to find a threshold value at this score, and also to estimate a prevalence of undernutrition in this population.

It will be a cross-sectional exploratory study to evaluate a diagnostic tool, the SARC-F score, with comparison between cases and controls.

The study will be conducted in a single center, a geriatric short-stay service. Participation in the study will be offered to any patient admitted to the geriatric ward, those who meet the inclusion criteria and do not have exclusion criteria will have to complete the SARC-F questionnaire during their stay, and to do the handgrip test and impedancemetry performed by a third party. Biological data (albumin, pre-albumin and C-Reactive Protein) and anthropometric data will be collected and analyzed to determine if the patient is malnourished or not, and the results of SARC-F will be compared between these 2 groups.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Screening
Official Title: Evaluation of the SARC-F Score as a Screening Tool for Undernutrition in a Geriatric Population
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: Group/Cohort 1
all patient SARC-F score, handgrip test and impedancemetry
Other: SARC-F score, handgrip test and impedancemetry
Participation in the study will be offered to any patient admitted to the geriatric ward, those who meet the inclusion criteria and do not have exclusion criteria will have to complete the SARC-F questionnaire during their stay, and to do the handgrip test and impedancemetry performed by a third party. Biological data (albumin, pre-albumin and C-Reactive Protein) and anthropometric data will be collected and analyzed to determine if the patient is malnourished or not, and the results of SARC-F will be compared between these 2 groups.




Primary Outcome Measures :
  1. score SARC-F [ Time Frame: at day 1 ]
    SARC-F score (dependent variable) defined by a questionnaire, completed by the patient during the stay at the clinic. This questionnaire includes 5 questions rated from 0 to 2 and is therefore 10 in total. It is admitted the presence of sarcopenia for a score greater than or equal to 4 according to the literature. However, there is currently no study defining a threshold for the diagnosis of undernutrition


Secondary Outcome Measures :
  1. SARC-F to predict undernutrition [ Time Frame: at day 1 ]
    discriminant values of SARC-F to predict undernutrition in the study population, considered qualitatively or quantitatively

  2. denutrition prevalence [ Time Frame: at day 1 ]
    overall prevalence of undernutrition in the study population



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 70 years and over
  • living at home or in nursing homes in Puy-de-Dôme
  • sent in short geriatric stay at the Grand Pré clinic by their general practioner, an emergency department or an EHPAD

Exclusion Criteria:

  • refusal to participate in the study
  • severe dementia preventing answering SARC-F questions
  • no fluency in the French language
  • patient with a pacemaker (contraindication of the use of impedancemetry)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553147


Contacts
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Contact: Patrick LACARIN 0473751195 placarin@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    0473751195    placarin@chu-clermontferrand.fr   
Principal Investigator: Nicolas FARIGON         
Sub-Investigator: Yves BOIRIE         
Sub-Investigator: Thibault MARTEL         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Nicolas FARIGON University Hospital, Clermont-Ferrand

Publications:

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03553147     History of Changes
Other Study ID Numbers: CHU-390
2017-A03050-53 ( Other Identifier: 2017-A03050-53 )
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
denutrition screening tool
SARC-F score
denutrition in geriatric population
sarc-f score associated with denutrition

Additional relevant MeSH terms:
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Sarcopenia
Malnutrition
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Nutrition Disorders