Alzheimer Disease Clinical Trial
Official title:
Alzheimer's Disease and Healing Gardens: Study of the Cognitive and Psycho-behavioral Effects of an Artistic Dimension
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.
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
TASKS SPECIFIC TO THE STUDY: MATERIALS
Interview methodology: The interrelationships between garden, art, cognition and behavior
will be assessed. The endpoints of these dimensions will be achieved by an analysis of
subject-psychologist interactions via interviews in the garden (in-context) and in
out-of-context mnemonic interviews. These interviews will be recorded and transcribed
verbatim. The interest of juxtaposing these two interview situations, in a comparative
analysis of interactional production, is to be able to access different cognitive skills in
order to analyze these skills. All of the data will be extracted through the quantitative
analysis of discursive productions stemming from Interlocutory Logic (Trognon and Batt,
2007, 2010, 2011). The investigators analyses will consist, on the one hand, of exploring
the public production of private thoughts of the subject (cognition and emotions) and
secondly, to modelize interactive behaviors. The interlocutory space will be both
referential and modal. All in all, the investigators will observe and analyze the eventual
discursive productions of the subject in reference to the "art, memory and life" garden,
whether they are related to the subject's experiences in the garden (in-context), to the
narrative situation in recounting his or her experience in the garden (out-of-context) or to
the spontaneous use of the garden for subjects in group A1. The implemented approach will
have a strong ecological perspective.
Interlocutory logic is an analysis method developed in the INTERPSY laboratory . This
pragmatic-dialogic method analyzes discourse in situations of interaction. This analytical
process is aimed at expliciting the basic components of communication, interlocutory
management and socio-cognitive-discursive events occurring in conversations.
For subjects in Group A:
Mood assessment: Cornell Scale for Depression in Dementia (CSDD, Cornell, 1988), translated
into French.
For subjects in Group A and in Group B
- Assessment of emotional events: Apathy Scale: Marin's Apathy Evaluation Scale (AES)
- Questionnaire on artistic and cultural activities (ACA) pertaining to all artistic and
cultural activities that the subject appreciates and/or is engaged in or has engaged
in.
- Assessment of general esthetic preferences: "General Esthetic Preference" (GEP) tool
- Designed along the lines of those used by Kawabata and Zeki and by Halpern et al. for
their respective studies (Kawabata and Zeki, 2010; Halpern et al., 2008).
- Materials: photographs representing works of art - paintings and sculptures - belonging
to three styles: figurative, stylized or abstract, each representing categories -
living or non-living.
- Task to be performed by the subject: for each photograph presented, the subject's task
is to express an esthetic judgment using a visual analogue scale. After collecting the
subject's esthetic judgment, his or her esthetic emotions will be assessed through two
propositional questions.
- Objective: Document the feelings relative to the person's preference for a certain
artistic style.
Interview-discovery and interview-knowledge of the garden (in-context) (30 min per
interview): During the walk-through, the subject, accompanied by the psychologist, will
observe the entire garden and its artistic elements. The subject will be queried through a
discussion aimed at promoting the expressing of immediate reactions on the artistic
dimensions. The analytical approach will enable to assess:
- the esthetic preferences of the artistic elements integrated in the garden
- the mnemonic and emotional processes (nature and frequency) that are mobilized during
the contemplation of the elements of the garden, whether vegetation or artistic.
- the expressions of well-being and curiosity prompted by the works of art
- the mnemonic processes referring to temporality and space
Out-of-context assessments (90 min per assessment):
- Mnemonic interview (about 30 min): in a closed office blinded to the outside, the
psychologist invites the subject to recall what he or she has experienced in the
garden. In other words, the subject is asked to narrate an experience outside of its
context. In this situation, the context must be formalized verbally which leads to the
mobilization of cognitive skills other than those mobilized in the first in-context
situation.
- General esthetic preferences (GEP tool): This assessment will reveal the perseverance
for certain esthetic preferences or, conversely, the detachment relative to certain
styles or categories addressed prior to the first walk in the garden.
- Mnemonic aspects of artistic elements " MémoArtZ " (MAZ) tool:
- Task to be performed by the subject: view photographs representing the various works of
art discovered in the garden, inserted amidst distractive elements.
- Instructions: "Show me the photograph that represents an item you saw in the garden".
- Aim: the analysis will enable to objectify potential encoded memory recalls referring
to the artistic elements of the garden.
- The mnemonic processes regarding temporality and space will also be brought to light
through exchanges initiated by open questions, particularly around the theme of the
current season of the year. The investigators will observe whether the fact of having
been in the garden allows the subject to change and readjust his or her eventually
inadequate response given at the MMSE (context aid).
- Mood assessment (CSDD) for subjects in group A only
- Assessment of emotional events (AES) for subjects in groups A and B.
ASSESSMENT SCHEDULE SPECIFIC TO THE RESEARCH
Group A " Alzheimer Group "
Subgroup A1 " Alzheimer group hospitalized at the Paul Spillmann Centre "
Inclusion visit With the investigator/physician
- Explanation of the objective and conduct of the research
- Upon participation consent: provision of the information document and of the consent
form and signing of the latter
- Informing of the trusted person or primary caregiver (with provision of an information
document)
- If patient consent: Informing of the attending physician
- Validation of inclusion and non-inclusion criteria
With the psychologist: T0:
- CSDD and AES scales
- ACA questionnaire
- GEP assessment
Visit 1 (as soon as possible after the inclusion visit)
Takes place in 2 stages on the same day:
- T1: Interview-discovery of the garden (in-context)
- T1+: Out-of-context assessment (mnemonic interview, GEP, MAZ, MMSE, CSDD, AES)
Spontaneous use of the garden
Visit 2 (after a three-day period of spontaneous use of the garden, consecutive or not, or
from the 4th day onward within a maximum delay of 10 days after visit 1)
- T2: Interview-knowledge of the garden (in-context)
- T2+: out-of-context interview (mnemonic interview, GEP, MAZ, MMSE, CSDD, AES)
Subgroup A2 "Alzheimer group monitored at the Resource and Research Memory Centre (CMRR) "
At the CMRR with the investigator/physician:
- Verification of inclusion and non-inclusion criteria in light of medical records
- Upon participation consent: provision of the information document and the consent form
- Informing of the trusted person or primary caregiver (with provision of an information
document)
- If patient consent: treating physician will be informed
- Scheduling of an appointment at the CPS
Visit 1 (over a single day, at the CPS)
Inclusion work-up with the investigator/physician of the CPS:
- Presentation of the study and careful reading of the information document
- Upon participation consent: signing of the consent form
- The person of trust or primary caregiver will be informed (an information document will
be delivered)
- If patient consent: Informing of the attending physician
- Validation of inclusion and non-inclusion criteria
With the psychologist:
- T0: CSDD and AES scales ACA questionnaire GEP assessment
- T1: Interview-discovery of the garden (in-context)
- T1+: Out-of-context assessment (mnemonic interview, GEP, MAZ, MMSE, CSDD, AES)
Visit 2 (without use of the garden) within a maximum delay of 10 days after visit 1
- T2: Interview-knowledge of the garden (in-context)
- T2+: out-of-context interview (mnemonic interview, GEP, MAZ, MMSE, CSDD, AES)
Group B: " healthy control group "
Visit 1 (over a single day, at the CPS)
With the investigator/physician: inclusion work-up:
- Presentation of the study and careful reading of the information document
- Upon participation consent: signing of the consent form
- Validation of inclusion and non-inclusion criteria
With the psychologist:
-T0: Neuropsychological assessment (90 min): neuropsychological tests used in routine
clinical practice CSDD and AES scale ACA questionnaire GEP assessment
- T1: Interview-discovery of the garden (in-context)
- T1+: out-of-context assessment (mnemonic interview, GEP, MAZ, MMSE, CSDD, AES)
Visit 2 (without use of the garden) within a maximum delay of 10 days after visit 1
- T2: Interview-knowledge of the garden (in-context)
- T2+: out-of-context interview (mnemonic interview, GEP, MAZ, MMSE, CSDD, AES) TOTAL
NUMBER OF PARTICIPANTS Taking into account situations leading to permanent study
discontinuations, 60 subjects will be included: 40 patients (group A) and 20 control
subjects (group B)
DURATION OF THE STUDY Duration of inclusion period: 3 years Duration of participation:
maximum 8 weeks for the patients (including the follow-up period); 11 days for control
subjects Total duration time: 38 months (including analysis period and presentation of data)
STATISTICAL ANALYSIS The descriptive analysis will be performed by computing frequencies for
categorical variables and mean and standard deviation or median and extreme values for
continuous variables. The analysis will include a comparison of the different time periods
of the study. Between-group comparison of frequencies (sick patients versus healthy subjects
or paired series at different study times) will be performed by a Fisher Chi2 test or
McNemar test, comparison of means by a nonparametric test or a paired t-test for paired
series according to the conditions of application of the tests. The alpha risk is set at 5%
for all analyses. An a posteriori power calculation will be performed retrospectively for
all statistical tests. The analysis will be carried out using the SAS version V9.3 software
package.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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