Alzheimer's Disease, Art and Garden

NCT02208193 | Unknown

• 1 other identifier: 2014-A00139-38
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer disease Art Healing gardens Discourse analysis

Outcome Measures

Primary Outcomes (1)

• Comparaison of the number of language acts in each category between AD and controls subjects

  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

  visit2 ( 10 days maximum after visit 1)

Secondary Outcomes (5)

• 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)

• 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)

• Score obtained with the specific assessment of emotional events scale (AES) for all subjects.

  visit2 ( 10 days maximum after visit 1)

Study Arms (2)

healthy controls group

EXPERIMENTAL

Healthy volunteers

Behavioral: Cognitive and psycho-behavioral effects of an artistic dimension

Alzheimer subjects group

EXPERIMENTAL

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)

Behavioral: Cognitive and psycho-behavioral effects of an artistic dimension

Interventions

Cognitive and psycho-behavioral effects of an artistic dimension BEHAVIORAL

Alzheimer subjects group; healthy controls group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• specific drug treatment for Alzheimer's disease, unchanged since at least 2 months (cholinesterase inhibitor and memantine)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHU Nancy

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Thérèse Rivasseau Jonveaux, MD

  CHU NANCY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thérèse Rivasseau Jonveaux, MD

CONTACT

+33(0)3 83 85 11 31; t.jonveaux@chu-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: August 4, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: September 1, 2017
• Last Updated: July 30, 2015

Record last verified: 2015-07

Locations

FR (1)