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

NCT05381259 | Unknown DMC

• 1 other identifier: 2022-A00357-36
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Horticultural Therapy

Outcome Measures

Primary Outcomes (1)

• 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)

  Eight months

Secondary Outcomes (2)

• Tinetti test : Assessment of walking and balance (Tinetti 1986).

  Eight months

• HAD Scale : Hospital Anxiety and Depression

  Eight months

Study Arms (1)

hortitherapy intervention versus control

OTHER

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".

Behavioral: hortitherapy in people living with Alzheimer's taking place in three different day care

Interventions

hortitherapy in people living with Alzheimer's taking place in three different day care BEHAVIORAL

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.

hortitherapy intervention versus control

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Médical Porte Verte: lead

Study Sites (1)

CentreMédicalPorteVerte

Versailles, 78000, France

RECRUITING

Study Officials

• Adèle DE MALHERBE, Dr

  Director of the Medico-Social Departement

  STUDY DIRECTOR

• Benjamin BAUBERT

  CENTRE 2 EHPAD Lépine Versailles

  PRINCIPAL INVESTIGATOR

• ophelie LEMBRET

  CENTRE 3 HPGM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marine ZAIBAT

CONTACT

+33039637491; mzaibat@hopitalporteverte.com

Fatima IZEDAREN, CRA

CONTACT

+33139637451; fizedaren@hopitalporteverte.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 19, 2022
• Study Start: May 4, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 10, 2023

Record last verified: 2022-05

Locations

FR (1)