- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03269500
Evaluation of the Applicability of Personalized Tools About Nutrition Education for Malnourished Older People (AlimAge)
May 12, 2022 updated by: University Hospital, Bordeaux
Describe the frequency of use of nutrition education tools for undernourished older people
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The description of the population will identify the characteristics of patients who use the tools and guide their use in patient care.
To realize an impact assessment, It necessary to identify specific criteria for inclusion.
It is important initially to assess the use of the nutritional tools.
The assessment of performance (obstacles and understanding), will be used to improve tools to optimize their use.
Study Type
Observational
Enrollment (Actual)
42
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pessac, France, 33600
- Bordeaux University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
75 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
malnourished elderly present on hospital day care
Description
Inclusion Criteria:
- Subject of 75 years or more.
- Hospitalized geriatric day hospital.
- Living at home, within a radius of 40 km around the hospital Xavier Arnozan.
- Subject or caregiver (s) read, understand and speak the french.
- Undernutrition (criteria of the French high authority for health (HAS) 2007)
- Agreed to participate in the study: compendium of the opposition
Exclusion Criteria:
- Subject not wishing to participate in the study,
- MMSE (Mini Mental State Examination) < 20, without presence of a caregiver with no cognitive problems scoring.
- Identified palliative care.
- Presenting a contraindication to oral feeding.
- Presence of supply of enteral or parenteral.
- Presence with a diagnosis of severe psychiatric pathology.
- Already participating in a study on undernutrition.
- One against medical advice.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
malnourished older people
The hospitalized elderly with swallowing and/or Mastication problems.
|
Use of different nutrition education tools :
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of use of the booklet and platelets
Time Frame: Day 14
|
number of use per week
|
Day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of the knowledge following the delivery of the tools
Time Frame: Day 14
|
Number of response "Yes" for 24 items about the tools
|
Day 14
|
|
Instrumental Activities of Daily Living
Time Frame: Day 1
|
Score of Instrumental Activities of Daily Living
|
Day 1
|
|
Assessment of quality of life scale
Time Frame: Day 1
|
Score of EQ-5D
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ornella SARRY, University Hospital, Bordeaux
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 5, 2017
Primary Completion (Actual)
August 7, 2018
Study Completion (Actual)
August 7, 2018
Study Registration Dates
First Submitted
August 28, 2017
First Submitted That Met QC Criteria
August 30, 2017
First Posted (Actual)
August 31, 2017
Study Record Updates
Last Update Posted (Actual)
May 13, 2022
Last Update Submitted That Met QC Criteria
May 12, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2016/51
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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