PsyDoMa : Non-drug Approaches at Home for Alzheimer's Patients With Psycho-behavioural Disorders (PSYDOMA)
PsyDoMa :Non-drug Approaches at Home for Alzheimer's Patients With Psycho-behavioural Disorders and Psycho-education for the Caregivers
Recruitment is carried out directly at the geriatric unit of the CIMIEZ University Hospital Center by geriatric doctors during day consultation or in short stay unit. The doctor wil select carer -patient couples more likely to take part in the study. The investigator will give them an informative leaflet and they will have to sign the consent form.
A diagnosis is made by the investigator. The patient will first have to undergo a neurocognitive assessment carried out at the Cimiez Hospital (test for the evaluation of a cognitive deficit) by a psychologist.
The non-drug approaches presented will be carried out directly at the participant's home with the help of the carer for therapeutic purposes.
The therapeutic objectives and the choice of approaches are specified within the Personalised Accompaniment Project (PAP).
The carer, if he or she wishes, participates in the sessions in order to reproduce the behaviours implemented by the psychologist.
Different workshops will be offered : Cooking, Art Therapy, Games, Multi-sensory, Soft Gymnastic, Relaxation, Music and Reminisence.
Patients will received three visits per week during six months. The carer will receive one visit per week for six months.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nice, France, 06000
- CHU de Nice
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
For Patients
- Men or women over 65 years old showing signs of cognitive decline
- Living at home with specific needs ( meals, etc.) and the regular presence of a carer,
- Living in Nice
- Diagnosed with Alzheimer or dementia
- Presence of at least one behavioural disorder
- Person who agreed and signed the informed consent or his/her guardian For Carers
- Carer of the patient who meets the inclusion criteria: spouse, children, siblings or other family members at home or a professional carer.
- Person involved during the motivational interviewing session regarding the psychoeducational program.
- Person who agreed and signed the informed consent.
Exclusion Criteria:
For patients :
- Elderly person presenting no NINCDS- ADRDA criteria,
- Presence of sensory deficit (hearing or vision)
- Person unable to communicate,
- No regular presence of a home carer, waiting for a place in a nursing home
- Aging psychiatric pathologies,
- Elderly person attending a day-care centre
For carers :
- carer absent or not present enough,
- Elderly person with undiagnosed behavioural disorders
- Drug treatment that can interfere with assessments (psychotropic drugs, neuroleptics, etc.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Non-drug approaches at home
Non-drug approaches at home three visits per week during six months and psycho-education for the caregivers one time per week for six months.
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Psychologist come once a week for the carer and three times a week for the patient
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Ratio of personalised care projects completed
Time Frame: at the end of 6 months
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at the end of 6 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Olivier GUERIN, PU-PH, Nice University Hospital, Gerontology Department
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-PP-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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