Alzheimer's Disease and Healing Gardens: Study of the Cognitive and Psycho-behavioral Effects of an Artistic Dimension
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Comparaison of the number of language acts in each category between AD and controls subjects
研究概览
简要总结
Gardens and art represent public spaces and support venues of interactions and emotions, seeking not only a variety of conversational themes but also various cognitive skills such as mnemonic skills. The cognitive and psycho-behavioral effects of art and the garden, jointly associated and made available to patients suffering from Alzheimer's disease, need to be evaluated.
MAIN OBJECTIVE Delineate the psychological scaffolding virtues of art and garden on cognitive and emotional processes by means of interview analyses in Alzheimer patients and control subjects based on the " art, memory and life " garden.
SECONDARY OBJECTIVES Adapt eco-psychosocial approaches of care management to Alzheimer patients:
- create assessment methods of:
- the therapeutic efficacy of the design of the " art, memory and life " garden,
- the perception of an artistic dimension in the living environment of those with Alzheimer's disease,
- establish:
- workshop applications using art and the garden for therapeutic purposes,
- general recommendations for the layout of the garden. PRIMARY ENDPOINT Quantitative data of discursive productions stemming from Interlocutory Logic (Trognon and Batt, 2007, 2010, 2011) for the analysis of interactive behaviors and the assessment of parameters including esthetic appraisals, well-being, mnemonic and emotional processes (frequency and nature of these processes) as well as spatio-temporal orientation.
SECONDARY ENDPOINTS
- Scores obtained in standard neuropsychological tests, in particular to assess spatio-temporal orientation (Folstein MMSE),
- Scores obtained with the " MemoArtZ " tool (MAZ) to evaluate the memorization of artistic elements of the garden,
- Scores from the " General Esthetic Preference " (GEP) tool to evaluate the consistency of general esthetic appreciations,
- Score obtained with the specific mood assessment scale (CSDD) for subjects in group A,
- Score obtained with the specific assessment of emotional events scale (AES) for all subjects.
RESEARCH METHODOLOGY
Open, monocentric, controlled (group of healthy control subjects) study.
Population: 2 groups:
Group A "Alzheimer group": patients with mild to severe stages of Alzheimer's disease: subgroup A1 "Alzheimer group hospitalized at the Paul Spillmann Centre (Centre Paul Spillmann, CPS)" (CHU de Nancy, France); subgroup A2 "Alzheimer group monitored at the Resource and Research Memory Centre (Centre Mémoire de Ressources et de Recherche, CMRR)" (CHU de Nancy, France) Group B "healthy control group": healthy volunteers
Therapeutic fallouts of this study will benefit Alzheimer patients in terms of better care management, notably: i) by determining the design, conception and layout of the gardens destined to these patients, ii) by developing the introduction of an artistic dimension to the design of such healing gardens and in their living environment, iii) by establishing workshop application perspectives using the contemplation of works of art and the garden for therapeutic purposes.
详细描述
RESEARCH METHODOLOGY / EXPERIMENTAL DESIGN
Open, monocentric, controlled (group of healthy control subjects) study.
Population: 2 groups:
Group A "Alzheimer group": patients with mild to severe stages of Alzheimer's disease: subgroup A1 "Alzheimer group hospitalized at the Paul Spillmann Centre (Centre Paul Spillmann, CPS)" (CHU de Nancy, France); subgroup A2 "Alzheimer group monitored at the Resource and Research Memory Centre (Centre Mémoire de Ressources et de Recherche, CMRR)" (CHU de Nancy, France) Group B "healthy control group": healthy volunteers
SPECIFIC ASSESSMENT PROCEDURES
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 60 to 100 years
- •able to walk independently, that is to say without recourse to aid, whether human or technical, except for a simple cane
- •have never been in the garden " art, memory and life " of the Paul Spillmann Centre
- •gave their written consent after receiving clear and intelligible written and oral information
- •with a diagnosis of a probable mild to severe stage of Alzheimer's disease according to NINCDS-ADRDA diagnostic criteria (McKhann et al., 1984) within the last 2 months prior to inclusion
- •score less than or equal to 4 on the Hachinski Ischemic Scale (Hachinski et al., 1984) within the last 2 months prior to inclusion
- •Folstein MMSE score between 7 and 24 inclusively within the last 2 months prior to inclusion
- •score of 4, 5 or 6 on the Reisberg Global Deterioration Scale (Reisberg et al., 1982) within a 2-month delay prior to inclusion
- •specific drug treatment for Alzheimer's disease, unchanged since at least 2 months (cholinesterase inhibitor and memantine)
- •no change in psychotropic treatment within 48 hours prior to inclusion
排除标准
- •lack of insurance coverage
- •sensory deficit interfering with the designated tasks in the study
- •phasic disorders interfering with the designated tasks in the study
- •history of head trauma (with loss of consciousness)
- •chronic alcoholism
- •refusal or inability to obtain the informed written consent of the subject
- •persons subject to a legal protection order
- •severe depression: score > 20 on the GDS (Geriatric Depression Scale) scale at inclusion
- •other neurological or psychiatric disorders potentially affecting the assessment
- •current or planned participation to other research involving neuropsychological evaluations and/or drug trial, up until the end of the current study
结局指标
主要结局
Comparaison of the number of language acts in each category between AD and controls subjects
时间窗: visit2 ( 10 days maximum after visit 1)
Each interaction between a subject and the psychologist is distributed into a interlocutory analysis table (Trognon and Batt, 2010 ; Batt, Trognon, Rivasseau-Jonveaux, Vernant and Jonveaux, 2014) where each utterance is noticed by its speech turn and its speech act. The second consists of a force (for example, an assertive force, as when I was eight, I loved the garden my parents owned) and a propositional content (for example, a feeling in its episodic context). Propositional content will be described according to its stimulus (for example, a kind of flower growing in the garden, a sculpture put into some place, etc.), to the interaction where it is produced and, more crucially, to the level of memory (procedural/semantics/episodics) it involves. These are the variables that will be then compared in using usual statistics between paired AD and control subjects at visit 1 and 2
次要结局
- Scores from the " General Esthetic Preference " (GEP) tool to evaluate the consistency of general esthetic appreciations,(visit2 ( 10 days maximum after visit 1))
- obtained with the specific mood assessment scale (CSDD) for subjects in group A(visit2 ( 10 days maximum after visit1))
- Scores obtained in standard neuropsychological tests, in particular to assess spatio-temporal orientation (Folstein MMSE),(visit2 ( 10 days maximum after visit 1))
- Scores obtained with the " MemoArtZ " tool (MAZ) to evaluate the memorization of artistic elements of the garden,(visit2 ( 10 days maximum after visit 1))
- Score obtained with the specific assessment of emotional events scale (AES) for all subjects.(visit2 ( 10 days maximum after visit 1))