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Clinical Trials/NCT05381259
NCT05381259
Unknown
Not Applicable

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

Centre Médical Porte Verte1 site in 1 country52 target enrollmentMay 4, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Horticultural Therapy
Sponsor
Centre Médical Porte Verte
Enrollment
52
Locations
1
Primary Endpoint
EVIBE : An instant assessment scale of perceived well-being in people with major cognitive problems.
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 4, 2022
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Centre Médical Porte Verte
Responsible Party
Principal Investigator
Principal Investigator

Adèle de Malherbe

Study coordinator

Centre Médical Porte Verte

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.

Outcomes

Primary Outcomes

EVIBE : An instant assessment scale of perceived well-being in people with major cognitive problems.

Time Frame: Eight months

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 Outcomes

  • Tinetti test : Assessment of walking and balance (Tinetti 1986).(Eight months)
  • HAD Scale : Hospital Anxiety and Depression(Eight months)

Study Sites (1)

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