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Alzheimer's Disease, Art and Garden (JAZ ART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02208193
Recruitment Status : Unknown
Verified July 2015 by Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : August 4, 2014
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Behavioral: Cognitive and psycho-behavioral effects of an artistic dimension Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Alzheimer's Disease and Healing Gardens: Study of the Cognitive and Psycho-behavioral Effects of an Artistic Dimension
Study Start Date : July 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: healthy controls group
Healthy volunteers
Behavioral: Cognitive and psycho-behavioral effects of an artistic dimension
Experimental: Alzheimer subjects group
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



Primary Outcome Measures :
  1. Comparaison of the number of language acts in each category between AD and controls subjects [ Time Frame: 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


Secondary Outcome Measures :
  1. Scores obtained in standard neuropsychological tests, in particular to assess spatio-temporal orientation (Folstein MMSE), [ Time Frame: visit2 ( 10 days maximum after visit 1) ]
  2. Scores obtained with the " MemoArtZ " tool (MAZ) to evaluate the memorization of artistic elements of the garden, [ Time Frame: visit2 ( 10 days maximum after visit 1) ]
  3. Scores from the " General Esthetic Preference " (GEP) tool to evaluate the consistency of general esthetic appreciations, [ Time Frame: visit2 ( 10 days maximum after visit 1) ]
  4. obtained with the specific mood assessment scale (CSDD) for subjects in group A [ Time Frame: visit2 ( 10 days maximum after visit1) ]
  5. Score obtained with the specific assessment of emotional events scale (AES) for all subjects. [ Time Frame: visit2 ( 10 days maximum after visit 1) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02208193


Contacts
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Contact: Thérèse Rivasseau Jonveaux, MD +33(0)3 83 85 11 31 t.jonveaux@chu-nancy.fr

Locations
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France
CHU Nancy Recruiting
Nancy, France, 54000
Contact: Thérèse Rivasseau Jonveaux, MD    +33(0)3 83 85 11 31    t.jonveaux@chu-nancy.fr   
Principal Investigator: Therese Rivasseau Jonveaux, MD         
Sub-Investigator: Athanase Benetos, Pr         
Sub-Investigator: Alina Pop, MD         
Sub-Investigator: Gabriel Malerba, MD         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Thérèse Rivasseau Jonveaux, MD CHU NANCY
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02208193    
Other Study ID Numbers: 2014-A00139-38
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015
Keywords provided by Central Hospital, Nancy, France:
Alzheimer disease Art Healing gardens Discourse analysis
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders