Conservation of Praxis in the Food and Alzheimer Disease

Alzheimer Disease Clinical Trial

— PRAXALIM  

Official title:

Impact of the Shape of Plates on the Conservation of Praxis in the Food at the Old Persons Suffering From Severe Insanities of Chap Alzheimer or Mixed in Institution.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743534
• Other study ID #: I09023
• Status: Completed
• Phase: N/A
• First received: May 30, 2011
• Last updated: August 19, 2016
• Start date: July 2011
• Est. completion date: July 2016

Study information

• Verified date: May 2011
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

The insanities, priority of public health in 2008, have significant prevalency in Limousin, region in the ageing demography (1/3 of the population is more than 60 years old against 1/5th of average in France). To prevent the lack of therapeutic solutions, for these evolutionary diseases, the new plan Alzheimer 2008-2012 encourages the research.

The insanities deprive gradually the individual of their autonomy, their personality and their identity. The help of an institution is sometimes inevitable. In the middle of this stressful environment, the patient affected by severe insanity, need marks.

The aspect of their old objects, significant for them, has to be prioritized because the institutional universe, often depersonalized doesn't mean anything for them. In front of repeated failures, they're hurt in their self respect.

The prevention of the undernutrition, comes by a preservation of praxis and pleasure at table. The institutional plate used in certain hospital sectors, is unpersonal (rectangular, divided) and can be destabilizing for the mentally ill person.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Men and women of more than 75 years

• Patients suffering from insanities of type Alzheimer

• Severe stage of the disease

• Residents in a Hospital for dependent old persons, with its own dining room

• Persons accommodated in the clinical service for more than 30 days

• EBS score <16

• Information in the participation of the resident, their legal representative and their family

• Patients affiliated to the Social Security.

• Filled and signed form of participation

• Patient having a appointed reliable person or one helping known whose references are indicated in the patient file.

Exclusion Criteria:

• Patients presenting pathologies being able to interfere with the evaluation

• Participating patients in another research for type clinical trial.

• Undernutrition patients

• Patients presenting oral hurts

• Protected patient or having nobody helping.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease

Locations

Country	Name	City	State
France	Limoges University hospital	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of Blandford Scale	Blandford Scale of which will be estimated before ( J0) and after ( J21) modification of the plate	2 days	No
Secondary	Score of Blandford scale	Blandford scale which will be estimated before ( J0) and after ( J42) modification of the plate	2 days	No