Evaluation of the SARC-F Score as a Screening Tool for Undernutrition in a Geriatric Population (GERIASARC)
Primary Purpose
Sarcopenia, Denutrition
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SARC-F score, handgrip test and impedancemetry
Sponsored by
About this trial
This is an interventional screening trial for Sarcopenia focused on measuring denutrition screening tool, SARC-F score, denutrition in geriatric population, sarc-f score associated with denutrition
Eligibility 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)
Sites / Locations
- CHU Clermont-FerrandRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group/Cohort 1
Arm Description
all patient SARC-F score, handgrip test and impedancemetry
Outcomes
Primary Outcome Measures
score SARC-F
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
SARC-F to predict undernutrition
discriminant values of SARC-F to predict undernutrition in the study population, considered qualitatively or quantitatively
denutrition prevalence
overall prevalence of undernutrition in the study population
Full Information
NCT ID
NCT03553147
First Posted
May 29, 2018
Last Updated
February 1, 2019
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT03553147
Brief Title
Evaluation of the SARC-F Score as a Screening Tool for Undernutrition in a Geriatric Population
Acronym
GERIASARC
Official Title
Evaluation of the SARC-F Score as a Screening Tool for Undernutrition in a Geriatric Population
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Denutrition
Keywords
denutrition screening tool, SARC-F score, denutrition in geriatric population, sarc-f score associated with denutrition
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
No masking
Allocation
N/A
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group/Cohort 1
Arm Type
Experimental
Arm Description
all patient SARC-F score, handgrip test and impedancemetry
Intervention Type
Other
Intervention Name(s)
SARC-F score, handgrip test and impedancemetry
Intervention Description
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 Measure Information:
Title
score SARC-F
Description
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
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
SARC-F to predict undernutrition
Description
discriminant values of SARC-F to predict undernutrition in the study population, considered qualitatively or quantitatively
Time Frame
at day 1
Title
denutrition prevalence
Description
overall prevalence of undernutrition in the study population
Time Frame
at day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas FARIGON
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Nicolas FARIGON
First Name & Middle Initial & Last Name & Degree
Yves BOIRIE
First Name & Middle Initial & Last Name & Degree
Thibault MARTEL
12. IPD Sharing Statement
Citations:
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25799486
Citation
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Results Reference
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Citation
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Citation
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Evaluation of the SARC-F Score as a Screening Tool for Undernutrition in a Geriatric Population
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