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临床试验/NCT02403245
NCT02403245已完成不适用

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

Paris West University Nanterre La Défense0 个研究点目标入组 60 人开始时间: 2012年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
主要终点
Observed social behaviours

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Observed social behaviours

时间窗: 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.

次要结局

  • Cognitive Status(Baseline)
  • Functional abilities(Baseline)
  • Depression(Baseline)
  • Psychological and behaviors disorders(Baseline)
  • Quality of life(Baseline)

研究者

发起方
Paris West University Nanterre La Défense
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-Bernard Mabire

psychologist and PhD psychologist Student

Paris West University Nanterre La Défense

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