Social Interactions Between People With Dementia in Nursing Home

Dementia Clinical Trial

Official title:

The Impact of a Social Stimulation on Social Interactions in Institutionalized People With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02403245
• Other study ID #: SID010
• Status: Completed
• Phase: N/A
• First received: March 16, 2015
• Last updated: March 25, 2015
• Start date: March 2012
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Paris West University Nanterre La Défense
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Dementia
• Social Interactions

Intervention

Other:
• Psychosocial stimulation
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Paris West University Nanterre La Défense	Radboud University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Cognitive Status	Scale of the Mini Mental State of examination scored on 30 points.	Baseline	No
Secondary	Functional abilities	Scale of the Instrumental Activities of Daily Living scored on 14 points. More the score is high more the people is independent in daily living.	Baseline	No
Secondary	Depression	Cornell Scale for Depression in Dementia scored on 38 points. More the score os high more the people is depressed with a threshold score of 10.	Baseline	No
Secondary	Psychological and behaviors disorders	Neuropsychiatric Inventory : hetero-evaluation of the psychological and behavioural disorders in 12 domains with the frequency of occurrence of the disorder, the intensity and the resounding on caregivers.	Baseline	No
Secondary	Quality of life	Hetero-evaluation scale named Alzheimer's Disease Related Quality of life expressed in percentage. A high score means a good quality of life.	Baseline	No