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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||No masking|
|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|
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.
- 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
- 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
- denutrition prevalence [ Time Frame: at day 1 ]overall prevalence of undernutrition in the study population
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
|Contact: Patrick LACARINemail@example.com|
|Clermont-Ferrand, France, 63003|
|Contact: Patrick LACARIN 0473751195 firstname.lastname@example.org|
|Principal Investigator: Nicolas FARIGON|
|Sub-Investigator: Yves BOIRIE|
|Sub-Investigator: Thibault MARTEL|
|Principal Investigator:||Nicolas FARIGON||University Hospital, Clermont-Ferrand|