NCT01314131

Brief Summary

The purpose is to evaluate patients' interests (patients in nursing home). Moreover the study aims to evaluate whether an activity for which the patient is interested in, allows a better involvement and stimulation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

April 29, 2011

Status Verified

January 1, 2011

Enrollment Period

6 months

First QC Date

March 11, 2011

Last Update Submit

April 28, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is the engagement duration for an activity, measured by the OME (Observational Measurement of Engagement) scale.

    First, a cognitive and behaviour assessment (specially autobiographical memory) is performed to patients. Then, the patient is proposed to do 5 activities. 4 of them correpond to activities for which he is interested in (depending on the assessment results). The therapist assesses if the patient is stimulated, by measuring the time for which he is involved in doing the activity (with OME Scale)

    10 times during two weeks

Study Arms (1)

Intervention group

EXPERIMENTAL
Behavioral: Stimulation group

Interventions

Patients living in nursing home can be enrolled in the study by giving their verbal consent. The trial lasts two weeks for each patients and it will be performed in three parts : * a cognitive and behaviour assessment : MMSE, BREF, NPI, IA * an interest questionnaire for patients. It contains 40 questions about activities. * the intervention : patients will be propose 5 activities. 4 of them are activities that patients are interested in. Each activity have to last 15 minutes and the stimulation is measured by a scale named "Observational Measurement of Engagement ".

Also known as: interest, autobiography
Intervention group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Alzheimer's disease
  • MMSE score between 12 and 24
  • Patient involved in organized activities in nursing home

You may not qualify if:

  • Patients:
  • Who are not able to understand and answer to questions for the study
  • \< 60 years of age
  • Who are not able to sit
  • Aphasic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Mémoire de Ressources et de Recherche

Nice, 06000, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Philippe ROBERT, PhD

    Centre Mémoire de Ressources et de Recherche

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe ROBERT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 14, 2011

Study Start

March 1, 2011

Primary Completion

September 1, 2011

Study Completion

June 1, 2012

Last Updated

April 29, 2011

Record last verified: 2011-01

Locations