NCT02403245

Brief Summary

The aim of this study is to evaluate the direct impact of one session of social stimulation on social interactions of people with moderate dementia living in nursing home in comparison of one session without direct social stimulation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

2.8 years

First QC Date

March 16, 2015

Last Update Submit

March 25, 2015

Conditions

Keywords

Social interactionsDementiaSocial stimulationDirect observation

Outcome Measures

Primary Outcomes (2)

  • Observed social behaviours

    social behaviours of residents observed and listed in an observations grid to analyze the results from observation in terms of components of behaviours expressed in means of observed behaviours.

    during 8 minutes before the session a

  • Observed social behaviours

    social behaviours of residents observed and listed in an observations grid to analyze the results from observation in terms of components of behaviours expressed in means of observed behaviours.

    during 8 minutes after the session

Secondary Outcomes (5)

  • Cognitive Status

    Baseline

  • Functional abilities

    Baseline

  • Depression

    Baseline

  • Psychological and behaviors disorders

    Baseline

  • Quality of life

    Baseline

Study Arms (2)

Psychosocial stimulation

EXPERIMENTAL

One session of a social stimulation

Other: Psychosocial stimulation

Control group

NO INTERVENTION

Residents are in a social controlled condition but without direct stimulation.

Interventions

Intervention consists in a session of social stimulation during about 40 minutes through where the speaker introduced himself to the residents and introduces the residents to each others. The date of the day was done to residents. Social stimulation consists here to an exercise about the four seasons. Residents are asked to mention the 4 seasons and to give all the characteristics they can about each season. Two exercises were proposed: 4 pictures of landscapes and residents were asked to tell which season is represent on the pictures and pictures of some fruits and residents tried to tell in which season we find the fruits. Finally, the psychologist speaks about the "four season" of the compositor Vivaldi and propose to the residents to listen some extracts of each pieces of music.

Psychosocial stimulation

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • presence of a diagnostic of dementia in medical report and a MMSE score between 9 and 20.

You may not qualify if:

  • arrival in the institution dating less than six months
  • invalidating visual or hearing disorders
  • phasic disorders not allowing a minimum of communication
  • significant behavioural disorders (which can disturb the meeting)
  • residents not fluent in French language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Jean-Bernard Mabire

    University Paris Ouest - EA 4430 - 200, Avenue de la République - 92001 Nanterre cedex

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
psychologist and PhD psychologist Student

Study Record Dates

First Submitted

March 16, 2015

First Posted

March 31, 2015

Study Start

March 1, 2012

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

March 31, 2015

Record last verified: 2015-03