NCT01743534

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 22, 2016

Status Verified

May 1, 2011

Enrollment Period

4.6 years

First QC Date

May 30, 2011

Last Update Submit

August 19, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Score of Blandford Scale

    Blandford Scale of which will be estimated before ( J0) and after ( J21) modification of the plate

    2 days

Secondary Outcomes (1)

  • Score of Blandford scale

    2 days

Study Arms (1)

Conservation of praxies and form plates

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient achieves of the Alzheimer's disease

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Limoges University hospital

Limoges, 87 000, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2011

First Posted

December 6, 2012

Study Start

July 1, 2011

Primary Completion

February 1, 2016

Study Completion

July 1, 2016

Last Updated

August 22, 2016

Record last verified: 2011-05

Locations