Personalized Dietary Advice After Discharge From Hospital in Geriatrics: Factors Associated With Improved Nutritional Status and Autonomy (DIETADOM)
Primary Purpose
Undernutrition of Elderly Peopole
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Personalized dietary management at home
Sponsored by
About this trial
This is an interventional other trial for Undernutrition of Elderly Peopole focused on measuring Elderly peopole, Undernutrition, Acute Geriatric
Eligibility Criteria
Inclusion Criteria:
- Unscheduled hospitalization of at least 4 days in acute geriatrics,
- Direct return to home or independent residence after hospitalization,
- To be domiciled in the Hauts-de-Seine department,
- Good understanding of the French language,
- Beneficiary of a social security scheme,
- Having read the briefing note and having consented to participate in the study by signing a written consent,
Exclusion Criteria:
- Severe cognitive impairment according to DMS-IV criteria,
- Inflammatory syndrome (CRP > 30 mg/l)
- Evolving cancer;
- Chronic respiratory failure,
- Stage IV heart failure
- long-term corticosteroids (> 10 mg/d prednisolone or equivalent),
- Enteral and parenteral nutrition at home,
- Chronic end-stage pathology;
- Inability to walk without human help
- Major person subject to a legal protection measure (guardianship, guardianship and safeguarding of justice)
Sites / Locations
- Geriactric Departement, Rives de Seine hopsitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patient malnourished or at risk of undernutrition
Not undernourished patients
Arm Description
Dietary follow-up at home: 4 visits (D15, D30, D60, D90)
Dietary follow-up at home: 3 visits ( D30,D60, D90)
Outcomes
Primary Outcome Measures
Screening for undernutrition in geriatric practice according the MNA-SF score (Short-Form Mini-Nutritional Assessment)
Secondary Outcome Measures
Assessment of the appetite according the VAS scale "Visual Analog Scale"
Assessment of teh degree of autonomy according AGGIR score
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Grab force measurement according the dynamometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04016532
Brief Title
Personalized Dietary Advice After Discharge From Hospital in Geriatrics: Factors Associated With Improved Nutritional Status and Autonomy
Acronym
DIETADOM
Official Title
Personalized Dietary Advice After Discharge From Hospital in Geriatrics: Factors Associated With Improved Nutritional Status and Autonomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gérond'if
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to identify the factors associated with the effectiveness of home dietary management in these elderly people returning home (personal home or independent residence) after hospitalization in acute geriatrics.
Detailed Description
Patient recruitment will be carried out in the 6 participating hospital centres.
All patients willing to participate, will benefit from an Inclusion Visit (J0): Conducted in hospital in acute geriatric services before discharge from hospital. Verification of inclusion criteria, collection of patient consent by investigator, assignment of patient identification number, declaration of inclusion, and collection by investigator of inclusion data (age, sex, weight, height, appetite, dietary intake scale, risk factors for undernutrition by HAS, albumin, CRP, exit treatment, ADL, IADL and GIR, technical aids for walking, presence of professional and non-professional home workers).
Home visit J7 (30 min to 1 hour): initial dietary assessment, will be carried out between 24 hours and 7 days after discharge from hospital. During this visit, the dietician will perform several measurements (MNA-SF, weight, height, appetite assessment, ingest/24h Consumption of NOCs if prescribed in hospital, Quality of Life, ADL, IADL, acceptance of visit, follow-up of dietary advice and intercurrent medical events).
Home visit J30, J60 (30 min to 1h): Made by the dietician, during these visits will be carried out various measurements and questionnaires: Appetite assessment, weight, ingesta/24h, consumption of NOCs, acceptance of the visit, follow up on dietary advice, compendiums of intercurrent medical events.
Home visit J90 = Final visit. This visit is identical to the initial assessment (J7). Patients who are undernourished or at risk of undernutrition will receive an additional J15 home visit (15 days after discharge from hospital). This visit will be identical to visits J30, J60.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undernutrition of Elderly Peopole
Keywords
Elderly peopole, Undernutrition, Acute Geriatric
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
338 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient malnourished or at risk of undernutrition
Arm Type
Other
Arm Description
Dietary follow-up at home: 4 visits (D15, D30, D60, D90)
Arm Title
Not undernourished patients
Arm Type
Other
Arm Description
Dietary follow-up at home: 3 visits ( D30,D60, D90)
Intervention Type
Dietary Supplement
Intervention Name(s)
Personalized dietary management at home
Intervention Description
Personalized dietary management at home to improve nutritional status.
Four (J7, J30, J60 and J90 for non-undernutrition patients) or five Home visits (J7, J15, J30 and J90 for undernutrition patients or at risk of undernutrition) by professional dietitians from Saveurs & Vie over a period of 3 months after discharge from the hospital: personalized dietary advice and recipe sheet.
There will be no change in medical prescriptions
Primary Outcome Measure Information:
Title
Screening for undernutrition in geriatric practice according the MNA-SF score (Short-Form Mini-Nutritional Assessment)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Assessment of the appetite according the VAS scale "Visual Analog Scale"
Time Frame
3 months
Title
Assessment of teh degree of autonomy according AGGIR score
Time Frame
Inclusion (0 day)
Title
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Time Frame
3 months
Title
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Time Frame
3 months
Title
Grab force measurement according the dynamometer
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unscheduled hospitalization of at least 4 days in acute geriatrics,
Direct return to home or independent residence after hospitalization,
To be domiciled in the Hauts-de-Seine department,
Good understanding of the French language,
Beneficiary of a social security scheme,
Having read the briefing note and having consented to participate in the study by signing a written consent,
Exclusion Criteria:
Severe cognitive impairment according to DMS-IV criteria,
Inflammatory syndrome (CRP > 30 mg/l)
Evolving cancer;
Chronic respiratory failure,
Stage IV heart failure
long-term corticosteroids (> 10 mg/d prednisolone or equivalent),
Enteral and parenteral nutrition at home,
Chronic end-stage pathology;
Inability to walk without human help
Major person subject to a legal protection measure (guardianship, guardianship and safeguarding of justice)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Dufour
Phone
+ 33 (0) 185781010
Email
isabelle.dufour@gerondif.org
First Name & Middle Initial & Last Name or Official Title & Degree
Prisca Lucas, PhD
Phone
+ 33 (0) 185751010
Email
prisca.lucas@gerondif.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine CHANSIAUX, MD
Organizational Affiliation
Geriatric Departement, Rives de Seine hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Geriactric Departement, Rives de Seine hopsital
City
Courbevoie
State/Province
Ile-De-France
ZIP/Postal Code
92400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Chansiaux, MD
Phone
+ 33 (0) 149043191
Email
cchansiaux@ch-rivesdeseine.fr
12. IPD Sharing Statement
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Personalized Dietary Advice After Discharge From Hospital in Geriatrics: Factors Associated With Improved Nutritional Status and Autonomy
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