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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Central Hospital, Nancy, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01692977
First received: August 16, 2012
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Alzheimer Disease
Other: neuropsychological assessment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Orienting Oneself in a Healing Garden: What Elements of the Design Are Used as Landmarks by Patients With Alzheimer's Disease ?

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline = inclusion visit ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline = inclusion visit ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alzheimer disease patients
Alzheimer disease patients
Other: neuropsychological assessment
Active Comparator: control
healthy control subjects.
Other: neuropsychological assessment

  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692977

Contacts
Contact: Therese Rivasseau Jonveaux, PhD +33(0)383851131 t.jonveaux@chu-nancy.fr

Locations
France
University Hospital of Nancy , Saint Julien Hospital, France Recruiting
Nancy, France, 54000
Contact: Therese Rivasseau Jonveaux, PhD    +33(0)383851131    t.jonveaux@chu-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Thérèse Rivasseau Jonveaux, PhD University Hospital of Nancy, France
  More Information

No publications provided

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01692977     History of Changes
Other Study ID Numbers: 2011-A00993-38
Study First Received: August 16, 2012
Last Updated: September 21, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014