- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01692977
What Elements of the Design of a Healing Garden Are Used as Landmarks by Patients With Alzheimer's Disease to Locate? (JAZ-TOP)
July 29, 2015 updated by: Central Hospital, Nancy, France
Orienting Oneself in a Healing Garden: What Elements of the Design Are Used as Landmarks by Patients With Alzheimer's Disease ?
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nancy, France, 54000
- University Hospital of Nancy , Saint Julien Hospital, France
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 90 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Alzheimer disease patients
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Active Comparator: control
healthy control subjects.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analyze nature and frequency of elements of the " art, memory and life " garden used as landmarks by Alzheimer's disease patients
Time Frame: Baseline = inclusion visit
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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.
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Baseline = inclusion visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: Baseline = inclusion visit
|
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.
|
Baseline = inclusion visit
|
|
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.
Time Frame: Baseline = inclusion visit
|
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.
|
Baseline = inclusion visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thérèse Rivasseau Jonveaux, PhD, University Hospital of Nancy, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
August 16, 2012
First Submitted That Met QC Criteria
September 21, 2012
First Posted (Estimate)
September 26, 2012
Study Record Updates
Last Update Posted (Estimate)
July 30, 2015
Last Update Submitted That Met QC Criteria
July 29, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-A00993-38
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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