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Conservation of Praxis in the Food and Alzheimer Disease (PRAXALIM)

This study is currently recruiting participants.
Verified May 2011 by University Hospital, Limoges
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01743534
First received: May 30, 2011
Last updated: December 4, 2012
Last verified: May 2011
History of Changes
  Purpose

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.


Condition
Alzheimer Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • Score of Blandford Scale [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Blandford Scale of which will be estimated before ( J0) and after ( J21) modification of the plate


Secondary Outcome Measures:
  • Score of Blandford scale [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Blandford scale which will be estimated before ( J0) and after ( J42) modification of the plate


Estimated Enrollment: 32
Study Start Date: July 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Conservation of praxies and form plates

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patient achieves of the Alzheimer's disease

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743534

Locations
France
Limoges University hospital Recruiting
Limoges, France, 87 000
Contact: Valerie DELAIDE     0555056921     valerie.delaide@chu-limoges.fr    
Sponsors and Collaborators
University Hospital, Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01743534     History of Changes
Other Study ID Numbers: I09023
Study First Received: May 30, 2011
Last Updated: December 4, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013