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Effects of Enriched Gardens in Nursing Home Residents With Dementia

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDEN
Sponsored by
RIVAGES
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer Disease focused on measuring Alzheimer, Enriched garden, Enriched environment, Dementia, Cognitive impairment, Functional autonomy

Eligibility Criteria

75 Years - 95 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Give consent
  • Ability walking alone
  • Alzheimer's disease

Exclusion Criteria:

  • No dementia
  • Severe dementia
  • Severe behavioural disorder
  • Inability to walk alone

Sites / Locations

  • Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Placebo Comparator

Experimental

Arm Label

GROUP ONE

GROUP TWO

GROUP THREE

Arm Description

The participants do not receive incentive to visit any gardens

The participants receive incentives by carers to visit regularly a conventional sensory garden

The participants receive incentives by carers to visit regularly an enriched garden

Outcomes

Primary Outcome Measures

Change in global cognitive function
Mini Mental Status Examination (MMSE) , 0-30, higher score is the better outcome
Change in functional independence
Activities of daily living (ADL), 0-6, higher score is the better outcome

Secondary Outcome Measures

Change in gait ability
Timed Up and Go test (sec), higher time is the worse outcome
Change in balance
Unipodal Stance (sec), higher time is the better outcome

Full Information

First Posted
March 3, 2021
Last Updated
May 21, 2021
Sponsor
RIVAGES
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1. Study Identification

Unique Protocol Identification Number
NCT04903171
Brief Title
Effects of Enriched Gardens in Nursing Home Residents With Dementia
Official Title
Effects of Enriched Gardens on Cognition and Independence of Nursing Home Residents With Dementia: a Cluster-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2020 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RIVAGES

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Comparing the effect of the frequentation of an enriched garden vs sensory conventional garden by nursing home residents with Alzheimer disease. The effects will be evaluated as regards to cognitive impairment (MMSE), autonomy (ADL) and prevention of falls (Unipodal stance and UpandGo Test)
Detailed Description
The cluster controlled trial is conducted over a six months period after recruitment of residents from 4 different nursing homes in France. The participants are distributed into 3 groups. One group does not receive incentive from carers to visit any garden, the second group receives incentives to visit regularly a conventional sensory garden and the third group receive incentives from carers to visit regularly an enriched garden. The study is conducted over a period of 6 months. All participants are giving consent to the study. They will be evaluated before and after over 4 different tests. MMSE (Mini Mental Status Examination) for cognitive impairment, ADL (Activity for day Living) for functional autonomy, TUG (Test up and Go) and Unipodal Stance for prevention of falls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer, Enriched garden, Enriched environment, Dementia, Cognitive impairment, Functional autonomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster controlled trial
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigators and outcomes assessor do not know which groups the participants belongs to
Allocation
Non-Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP ONE
Arm Type
No Intervention
Arm Description
The participants do not receive incentive to visit any gardens
Arm Title
GROUP TWO
Arm Type
Placebo Comparator
Arm Description
The participants receive incentives by carers to visit regularly a conventional sensory garden
Arm Title
GROUP THREE
Arm Type
Experimental
Arm Description
The participants receive incentives by carers to visit regularly an enriched garden
Intervention Type
Other
Intervention Name(s)
INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDEN
Intervention Description
Carers invites every the participants of group 2 and 3 visiting their respective gardens (enriched or conventional sensory garden)
Primary Outcome Measure Information:
Title
Change in global cognitive function
Description
Mini Mental Status Examination (MMSE) , 0-30, higher score is the better outcome
Time Frame
6 MONTHS
Title
Change in functional independence
Description
Activities of daily living (ADL), 0-6, higher score is the better outcome
Time Frame
6 MONTHS
Secondary Outcome Measure Information:
Title
Change in gait ability
Description
Timed Up and Go test (sec), higher time is the worse outcome
Time Frame
6 MONTHS
Title
Change in balance
Description
Unipodal Stance (sec), higher time is the better outcome
Time Frame
6 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Give consent Ability walking alone Alzheimer's disease Exclusion Criteria: No dementia Severe dementia Severe behavioural disorder Inability to walk alone
Facility Information:
Facility Name
Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université
City
Ivry-sur-Seine
State/Province
Val De Marne
ZIP/Postal Code
94200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will only be available to study reviewers

Learn more about this trial

Effects of Enriched Gardens in Nursing Home Residents With Dementia

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