- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04016532
Personalized Dietary Advice After Discharge From Hospital in Geriatrics: Factors Associated With Improved Nutritional Status and Autonomy (DIETADOM)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Isabelle Dufour
- Phone Number: + 33 (0) 185781010
- Email: isabelle.dufour@gerondif.org
Study Contact Backup
- Name: Prisca Lucas, PhD
- Phone Number: + 33 (0) 185751010
- Email: prisca.lucas@gerondif.org
Study Locations
-
-
Ile-De-France
-
Courbevoie, Ile-De-France, France, 92400
- Recruiting
- Geriactric Departement, Rives de Seine hopsital
-
Contact:
- Christine Chansiaux, MD
- Phone Number: + 33 (0) 149043191
- Email: cchansiaux@ch-rivesdeseine.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patient malnourished or at risk of undernutrition
Dietary follow-up at home: 4 visits (D15, D30, D60, D90)
|
Personalized dietary management at home to improve nutritional status.
|
Other: Not undernourished patients
Dietary follow-up at home: 3 visits ( D30,D60, D90)
|
Personalized dietary management at home to improve nutritional status.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Screening for undernutrition in geriatric practice according the MNA-SF score (Short-Form Mini-Nutritional Assessment)
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of the appetite according the VAS scale "Visual Analog Scale"
Time Frame: 3 months
|
3 months
|
Assessment of teh degree of autonomy according AGGIR score
Time Frame: Inclusion (0 day)
|
Inclusion (0 day)
|
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Time Frame: 3 months
|
3 months
|
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Time Frame: 3 months
|
3 months
|
Grab force measurement according the dynamometer
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Christine CHANSIAUX, MD, Geriatric Departement, Rives de Seine hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-A03458-47
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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