Ignite Creation Date:
2024-05-06 @ 3:05 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02208193
Status:
UNKNOWN
Last Update Posted:
2015-07-30
First Post:
2014-07-22
Brief Title:
Alzheimers Disease Art and Garden
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Alzheimers Disease and Healing Gardens Study of the Cognitive and Psycho-behavioral Effects of an Artistic Dimension
Status:
UNKNOWN
Status Verified Date:
2015-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JAZ ART
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 Alzheimers 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 Alzheimers 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 Alzheimers 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
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 Alzheimers 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 Alzheimers 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
Detailed Description:
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 Alzheimers 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 subjects 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 Marins Apathy Evaluation Scale AES
Questionnaire on artistic and cultural activities ACA pertaining to all artistic and cultural activities that the subject appreciates andor 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 subjects task is to express an esthetic judgment using a visual analogue scale After collecting the subjects esthetic judgment his or her esthetic emotions will be assessed through two propositional questions
Objective Document the feelings relative to the persons 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 investigatorphysician
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 investigatorphysician
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 investigatorphysician 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 investigatorphysician 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 V93 software package
Open monocentric controlled group of healthy control subjects study
Population 2 groups
Group A Alzheimer group patients with mild to severe stages of Alzheimers 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 subjects 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 Marins Apathy Evaluation Scale AES
Questionnaire on artistic and cultural activities ACA pertaining to all artistic and cultural activities that the subject appreciates andor 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 subjects task is to express an esthetic judgment using a visual analogue scale After collecting the subjects esthetic judgment his or her esthetic emotions will be assessed through two propositional questions
Objective Document the feelings relative to the persons 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 investigatorphysician
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 investigatorphysician
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 investigatorphysician 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 investigatorphysician 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 V93 software package
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None