Effects of Enriched Gardens in Nursing Home Residents With Dementia

NCT ID: NCT04903171

Last Updated: 2021-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-15

Study Completion Date

2020-10-15

Brief Summary

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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

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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.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Cluster controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The investigators and outcomes assessor do not know which groups the participants belongs to

Study Groups

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GROUP ONE

The participants do not receive incentive to visit any gardens

Group Type NO_INTERVENTION

No interventions assigned to this group

GROUP TWO

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

Group Type PLACEBO_COMPARATOR

INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDEN

Intervention Type OTHER

Carers invites every the participants of group 2 and 3 visiting their respective gardens (enriched or conventional sensory garden)

GROUP THREE

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

Group Type EXPERIMENTAL

INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDEN

Intervention Type OTHER

Carers invites every the participants of group 2 and 3 visiting their respective gardens (enriched or conventional sensory garden)

Interventions

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INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDEN

Carers invites every the participants of group 2 and 3 visiting their respective gardens (enriched or conventional sensory garden)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No dementia
* Severe dementia
* Severe behavioural disorder
* Inability to walk alone
Minimum Eligible Age

75 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RIVAGES

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université

Ivry-sur-Seine, Val De Marne, France

Site Status

Countries

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France

Other Identifiers

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RIVAGES

Identifier Type: -

Identifier Source: org_study_id

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