Clinical trial NCT02403245: Social Interactions Between People With Dementia in Nursing Home
Official title: The Impact of a Social Stimulation on Social Interactions in Institutionalized People With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Social Interactions
Keywords: Social interactions
Dementia
Social stimulation
Direct observation
Lead sponsor: Paris West University Nanterre La Défense
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
First posted: 2015-03-31
Enrollment: 60
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Detailed description: 60 people with moderate dementia living in a french nursing homme participated in this study. Residents gave oral consent twice to participate. They were classified in groups of six residents taking into account socio-demographic and medical characteristics. Two experimental conditions were proposed : 1. a social stimulation session (36 residents) and 2. a control group without direct social stimulation (24 residents). Collected socio-demographic and medical characteristics are age, gender, timf of institutionalization, sociocultural level, marital status and diagnostic hypothesis. Before the study, scales and questionnaires were used to assess cognitive status with the Mini Mental State Examination (Folstein et al, 1975); functional abilities with Instrumental Activities of Daily Living (Lawton and Brody, 1969); depression with the Cornell Scale for Depression in Dementia (Alexopoulos et al, 1988); psychological and behavioural disorders with the Neuropsychiatric Inventory (Cummings et al, 1994); and the quality of life with the Alzheimer's Disease Related Quality of Life (Rabins et al, 1999).

Social interactions are video taped and analyzed in a grid of observation.

The aim of the study is to see if there is an impact on social interactions after just one social stimulation session compared to a control group situation. Expected results are that residents of the social stimulation group will have more social interactions between us than the resident of the control group.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Observed social behaviours
timeFrame: during 8 minutes before the session a
measure: Observed social behaviours
timeFrame: during 8 minutes after the session
Secondary outcomes:
measure: Cognitive Status
timeFrame: Baseline
measure: Functional abilities
timeFrame: Baseline
measure: Depression
timeFrame: Baseline
measure: Psychological and behaviors disorders
timeFrame: Baseline
measure: Quality of life
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: University Paris Ouest - EA 4430 - 200, Avenue de la République - 92001 Nanterre cedex
name: Jean-Bernard Mabire
role: PRINCIPAL_INVESTIGATOR
References: