- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02403245
Social Interactions Between People With Dementia in Nursing Home
The Impact of a Social Stimulation on Social Interactions in Institutionalized People With Dementia
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Psychosocial stimulation
One session of a social 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.
|
No Intervention: Control group
Residents are in a social controlled condition but without direct stimulation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Observed social behaviours
Time Frame: during 8 minutes before the session a
|
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
Time Frame: during 8 minutes after the session
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive Status
Time Frame: Baseline
|
Scale of the Mini Mental State of examination scored on 30 points.
|
Baseline
|
Functional abilities
Time Frame: Baseline
|
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
|
Depression
Time Frame: Baseline
|
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
|
Psychological and behaviors disorders
Time Frame: Baseline
|
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
|
Quality of life
Time Frame: Baseline
|
Hetero-evaluation scale named Alzheimer's Disease Related Quality of life expressed in percentage.
A high score means a good quality of life.
|
Baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jean-Bernard Mabire, University Paris Ouest - EA 4430 - 200, Avenue de la République - 92001 Nanterre cedex
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SID010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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