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What Elements of the Design of a Healing Garden Are Used as Landmarks by Patients With Alzheimer's Disease to Locate? (JAZ-TOP)

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
neuropsychological assessment
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All subjects (groups A and B):

  • able to walk autonomously, that is without help, whether human or technical, except for a walking cane
  • are aged 65 to 90 years
  • have never been in the "art, memory and life" garden at the Paul SPILLMANN Centre prior to the study
  • have given their written consent after receiving clear and intelligible oral and written information.

Group A : patients with Alzheimer's disease:

  • diagnosis of probable Alzheimer's disease according to NINCDS-ADRDA diagnostic criteria (Mc KHANN et al., 1984)
  • score less than or equal to 4 on the Hachinski ischemic scale (Hachinski et al., 1984)
  • Folstein MMSE score between 10 and 24 inclusively
  • score equal to 5 or 6 on the Reisberg Global Deterioration Scale (REISBERG et al., 1982).
  • stable, specific treatment of Alzheimer's disease (cholinesterase and memantine)
  • taking of psychotropic drugs authorized, but no change in treatment during at least the last 48 hours

Group B: healthy control subjects:

  • absence of dementia according to NINCDS-ADRDA criteria (Mc KHANN et al., 1984)
  • normal performance on Folstein MMSE, according to the GRECO (en français : Groupe de REflexions sur les Evaluations Cognitives) standards (Reflection Group on Cognitive Assessments)

Exclusion Criteria:

For all subjects (groups A and B):

  • Absence of social security coverage
  • sensory deficit interfering with the task
  • aphasia interfering with the task
  • history of head trauma (with loss of consciousness)
  • chronic alcoholism
  • refusal or inability to obtain written informed consent form from the patient
  • legally protected person
  • severe depression: score higher than 20 on the 30-item Geriatric Depression Scale (GDS)

Group A : patients with Alzheimer's disease:

  • other neurological or psychiatric diseases that may affect the assessment Group B: healthy control subjects
  • neurological or psychiatric diseases that may affect the assessment

Sites / Locations

  • University Hospital of Nancy , Saint Julien Hospital, France

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alzheimer disease patients

control

Arm Description

Alzheimer disease patients

healthy control subjects.

Outcomes

Primary Outcome Measures

Analyze nature and frequency of elements of the " art, memory and life " garden used as landmarks by Alzheimer's disease patients
To describe and compare nature and frequency of elements involved in orientation decisions and the cognitive map, between a group of subjects with Alzheimer's disease and a group of healthy control subjects.

Secondary Outcome Measures

Study the characteristics of the elements that contributed to decision-making regarding spatial orientation, the cognitive map, correlations between success in experimental, neuropsychological assessment in Alzheimer disease and healthy control subjects.
To identify, through analysis of interviews based on problem solving and interlocutory logic (TROGNON and BATT, 2007,2010, 2011), the characteristics of the elements of the " art, memory and life " garden that contributed to decision-making regarding spatial orientation and the development of a mental representation of the garden, in patients with Alzheimer's disease and healthy elderly subjects.
Study the characteristics of the elements that contributed to decision-making regarding spatial orientation, the cognitive map, correlations between success in experimental, neuropsychological assessment in Alzheimer disease and healthy control subjects.
To study the correlation between the degree of success in experimental tasks (route learning, cognitive map) and standard and specific neuropsychological assessment (visuospatial skills) of individuals with Alzheimer's disease and healthy control subjects.

Full Information

First Posted
August 16, 2012
Last Updated
July 29, 2015
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT01692977
Brief Title
What Elements of the Design of a Healing Garden Are Used as Landmarks by Patients With Alzheimer's Disease to Locate?
Acronym
JAZ-TOP
Official Title
Orienting Oneself in a Healing Garden: What Elements of the Design Are Used as Landmarks by Patients With Alzheimer's Disease ?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The disruption of spatial orientation is considered the second most common cognitive symptom of dementia, affecting nearly all activities of daily living. Research in the field of environmental psychology has helped to highlight the influence of the environment on patients with Alzheimer's disease or related syndromes. With regard to spatial orientation, it has been shown that an environment can provide support for cognitive failures in subjects if that particular space is adapted. While numerous studies have focused on the architectural environment (hospital, housing facility), none have explored the ability of patients to orient themselves in a natural environment such as a garden. Yet, in recent years, such gardens, known as healing gardens, have emerged in housing and care facilities, providing genuine support for the care management of patients with Alzheimer-type dementia. Various works have been published outlining recommendations for their management. However, with regard to spatial orientation, none of the available research has explored the basic principles on which to rely on in order to organize the elements of outdoor spaces into itineraries that promote orientation, according to ZEISEL and TYSON (1999). In the absence of such data, these authors recommend relying on five elements, identified by Lynch in his landmark book "Image of the City" (1960), that people use to orient themselves and find their way. These are " paths ", " edges ", " districts ", " nodes " and " landmarks ". The hypothesis to verify is that patients with Alzheimer's disease do not rely on the same elements of the garden as non-Alzheimer's subjects in making orientation decisions and to mentally picture this environment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alzheimer disease patients
Arm Type
Experimental
Arm Description
Alzheimer disease patients
Arm Title
control
Arm Type
Active Comparator
Arm Description
healthy control subjects.
Intervention Type
Other
Intervention Name(s)
neuropsychological assessment
Primary Outcome Measure Information:
Title
Analyze nature and frequency of elements of the " art, memory and life " garden used as landmarks by Alzheimer's disease patients
Description
To describe and compare nature and frequency of elements involved in orientation decisions and the cognitive map, between a group of subjects with Alzheimer's disease and a group of healthy control subjects.
Time Frame
Baseline = inclusion visit
Secondary Outcome Measure Information:
Title
Study the characteristics of the elements that contributed to decision-making regarding spatial orientation, the cognitive map, correlations between success in experimental, neuropsychological assessment in Alzheimer disease and healthy control subjects.
Description
To identify, through analysis of interviews based on problem solving and interlocutory logic (TROGNON and BATT, 2007,2010, 2011), the characteristics of the elements of the " art, memory and life " garden that contributed to decision-making regarding spatial orientation and the development of a mental representation of the garden, in patients with Alzheimer's disease and healthy elderly subjects.
Time Frame
Baseline = inclusion visit
Title
Study the characteristics of the elements that contributed to decision-making regarding spatial orientation, the cognitive map, correlations between success in experimental, neuropsychological assessment in Alzheimer disease and healthy control subjects.
Description
To study the correlation between the degree of success in experimental tasks (route learning, cognitive map) and standard and specific neuropsychological assessment (visuospatial skills) of individuals with Alzheimer's disease and healthy control subjects.
Time Frame
Baseline = inclusion visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All subjects (groups A and B): able to walk autonomously, that is without help, whether human or technical, except for a walking cane are aged 65 to 90 years have never been in the "art, memory and life" garden at the Paul SPILLMANN Centre prior to the study have given their written consent after receiving clear and intelligible oral and written information. Group A : patients with Alzheimer's disease: diagnosis of probable Alzheimer's disease according to NINCDS-ADRDA diagnostic criteria (Mc KHANN et al., 1984) score less than or equal to 4 on the Hachinski ischemic scale (Hachinski et al., 1984) Folstein MMSE score between 10 and 24 inclusively score equal to 5 or 6 on the Reisberg Global Deterioration Scale (REISBERG et al., 1982). stable, specific treatment of Alzheimer's disease (cholinesterase and memantine) taking of psychotropic drugs authorized, but no change in treatment during at least the last 48 hours Group B: healthy control subjects: absence of dementia according to NINCDS-ADRDA criteria (Mc KHANN et al., 1984) normal performance on Folstein MMSE, according to the GRECO (en français : Groupe de REflexions sur les Evaluations Cognitives) standards (Reflection Group on Cognitive Assessments) Exclusion Criteria: For all subjects (groups A and B): Absence of social security coverage sensory deficit interfering with the task aphasia interfering with the task history of head trauma (with loss of consciousness) chronic alcoholism refusal or inability to obtain written informed consent form from the patient legally protected person severe depression: score higher than 20 on the 30-item Geriatric Depression Scale (GDS) Group A : patients with Alzheimer's disease: other neurological or psychiatric diseases that may affect the assessment Group B: healthy control subjects neurological or psychiatric diseases that may affect the assessment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thérèse Rivasseau Jonveaux, PhD
Organizational Affiliation
University Hospital of Nancy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Nancy , Saint Julien Hospital, France
City
Nancy
ZIP/Postal Code
54000
Country
France

12. IPD Sharing Statement

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What Elements of the Design of a Healing Garden Are Used as Landmarks by Patients With Alzheimer's Disease to Locate?

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