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Effectiveness of Hortitherapy on the Immediate Well-being of Elderly People With Alzheimer's Disease or Related in Day Care (Hortitherapy)

Primary Purpose

Horticultural Therapy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
hortitherapy in people living with Alzheimer's taking place in three different day care
Sponsored by
Centre Médical Porte Verte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Horticultural Therapy

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient having signed an informed and written consent,
  • Patient aged over 60,
  • Patient with Alzheimer's or related disease,
  • Patient benefiting from day care,
  • Patient under guardianship or curatorship.

Exclusion Criteria:

  • Patient in period of adaptation in day care,
  • Patient in temporary care at day care,
  • Patient having participated in less than 4 horticultural workshops during the cycle,
  • Patient with severe asthma and/or an allergy that does not allow workshops to be carried out,
  • Patient with major behavioral problems that make it impossible to carry out the workshops.

Sites / Locations

  • CentreMédicalPorteVerteRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

hortitherapy intervention versus control

Arm Description

Horticultural therapy refers to physical and psychic therapy by nature by focusing on the action of gardening on the body, intellect, psych and mind. Horticultural in the form of therapeutic gardening serves as a support to help and treat various pathologies in the brain. It is a form of curative treatment exploiting the planting and maintenance of garden. The term is a contraction of " horticultural " and " therapy".

Outcomes

Primary Outcome Measures

EVIBE : An instant assessment scale of perceived well-being in people with major cognitive problems.
The score of the EVIBE scale is a numerical score between 0 and 5, it will be compared between the two groups, the patients will be integrated randomly in order to take into account the correlation between the data due to the repeated nature of the measurements. The regression application conditions will be checked graphically on the residuals. If they are not respected, alternative strategies will be studied (log transformation, bootstrap test)

Secondary Outcome Measures

Tinetti test : Assessment of walking and balance (Tinetti 1986).
The Tinetti test is an effective and reproducible tool for the assessment of the risk of falling, its administration time is approximately 5 to 10 minutes and evaluates static and dynamic balance.
HAD Scale : Hospital Anxiety and Depression
The advantage of this scale is to quickly and simultaneously assess depressive and anxious dimensions using a short questionnaire. The scale is collected on inclusion and after the 8 weeks of treatment.

Full Information

First Posted
May 3, 2022
Last Updated
January 6, 2023
Sponsor
Centre Médical Porte Verte
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1. Study Identification

Unique Protocol Identification Number
NCT05381259
Brief Title
Effectiveness of Hortitherapy on the Immediate Well-being of Elderly People With Alzheimer's Disease or Related in Day Care
Acronym
Hortitherapy
Official Title
Effectiveness of Hortitherapy on the Immediate Well-being of Elderly People With Alzheimer's Disease or Related in Day Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Médical Porte Verte

4. Oversight

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

5. Study Description

Brief Summary
Currently, there are an estimated 47 million people with dementia worldwide, with approximately 10 million new cases diagnosed each year. This figure is expected to triple to 130 million in 2050. In France, the number of dementia cases is estimated at 754,000 and could reach 1,813,000 in 2050. In a recent literature review, researchers highlighted the many benefits of horticultural therapy and garden environments for people with Alzheimer's or cognitive disorders. They include: alleviating pain, improving attention, decreasing stress, relieving agitation, decreasing the use of medications, such as antipsychotics, as well as reducing falls. Gardening offers a non-pharmacological approach to achieving these goals and could improve the quality of life for people with Alzheimer's disease or another dementia. As part of a care solution, support services that include social activities, such as gardening, reduce the need for more intrusive and expensive care solutions. The objective of this research is to evaluate the impact of horticultural
Detailed Description
This research is an interventional study involving the human person of category 2 involving only minimal risks and constraints, it is prospective, multicenter and non-randomized. The study will take place with users of the Lépine Versailles day care centre, the La Porte Verte hospital and the Les Magnolias Geriatric Center, living with cognitive disorders. For the purposes of this study, understanding the instructions is required. The people welcomed will participate in their usual day supervised by the day reception team. Part of the group having agreed to participate in the study will carry out the horticultural workshop while the other group will benefit from the workshop usually offered. The study will be done with 52 users with the participation of a supervisor to animate the workshops of the different groups. Each site will have a workshop that will take place in the morning from 11 a.m. to 12 p.m. and one in the afternoon from 2:30 p.m. to 3:30 p.m. This will make it possible to compare the well-being of users according to the time of the workshop.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Part of the group having agreed to participate in the study will carry out the horticultural workshop while the other group will benefit from the workshop usually offered.
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hortitherapy intervention versus control
Arm Type
Other
Arm Description
Horticultural therapy refers to physical and psychic therapy by nature by focusing on the action of gardening on the body, intellect, psych and mind. Horticultural in the form of therapeutic gardening serves as a support to help and treat various pathologies in the brain. It is a form of curative treatment exploiting the planting and maintenance of garden. The term is a contraction of " horticultural " and " therapy".
Intervention Type
Behavioral
Intervention Name(s)
hortitherapy in people living with Alzheimer's taking place in three different day care
Intervention Description
6 users benefiting from the horticultural workshop and 6 others from a usual workshop (control group) This control group will benefit from its usual workshop while the other group will participate in the horticultural workshop. If it is impossible to carry out the workshops outdoors (rain or high heat), the day reception centers will provide a room to allow the workshops to be carried out. They will be adapted in terms of activities and materials.
Primary Outcome Measure Information:
Title
EVIBE : An instant assessment scale of perceived well-being in people with major cognitive problems.
Description
The score of the EVIBE scale is a numerical score between 0 and 5, it will be compared between the two groups, the patients will be integrated randomly in order to take into account the correlation between the data due to the repeated nature of the measurements. The regression application conditions will be checked graphically on the residuals. If they are not respected, alternative strategies will be studied (log transformation, bootstrap test)
Time Frame
Eight months
Secondary Outcome Measure Information:
Title
Tinetti test : Assessment of walking and balance (Tinetti 1986).
Description
The Tinetti test is an effective and reproducible tool for the assessment of the risk of falling, its administration time is approximately 5 to 10 minutes and evaluates static and dynamic balance.
Time Frame
Eight months
Title
HAD Scale : Hospital Anxiety and Depression
Description
The advantage of this scale is to quickly and simultaneously assess depressive and anxious dimensions using a short questionnaire. The scale is collected on inclusion and after the 8 weeks of treatment.
Time Frame
Eight months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient having signed an informed and written consent, Patient aged over 60, Patient with Alzheimer's or related disease, Patient benefiting from day care, Patient under guardianship or curatorship. Exclusion Criteria: Patient in period of adaptation in day care, Patient in temporary care at day care, Patient having participated in less than 4 horticultural workshops during the cycle, Patient with severe asthma and/or an allergy that does not allow workshops to be carried out, Patient with major behavioral problems that make it impossible to carry out the workshops.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marine ZAIBAT
Phone
+33039637491
Email
mzaibat@hopitalporteverte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fatima IZEDAREN, CRA
Phone
+33139637451
Email
fizedaren@hopitalporteverte.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adèle DE MALHERBE, Dr
Organizational Affiliation
Director of the Medico-Social Departement
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Benjamin BAUBERT
Organizational Affiliation
CENTRE 2 EHPAD Lépine Versailles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ophelie LEMBRET
Organizational Affiliation
CENTRE 3 HPGM
Official's Role
Principal Investigator
Facility Information:
Facility Name
CentreMédicalPorteVerte
City
Versailles
ZIP/Postal Code
78000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adèle de Malherbe, Dr
Phone
0033139637444
Email
ademalherbe@hopitalporteverte.com
First Name & Middle Initial & Last Name & Degree
Dr

12. IPD Sharing Statement

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Effectiveness of Hortitherapy on the Immediate Well-being of Elderly People With Alzheimer's Disease or Related in Day Care

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