Clinical trial NCT04573829: PsyDoMa : Non-drug Approaches at Home for Alzheimer's Patients With Psycho-behavioural Disorders
Official title: PsyDoMa :Non-drug Approaches at Home for Alzheimer's Patients With Psycho-behavioural Disorders and Psycho-education for the Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Disorder
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
Collaborators: name: Fondation Mederic Alzheimer
First posted: 2020-10-05
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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.).

Primary outcomes:
measure: Ratio of personalised care projects completed
timeFrame: at the end of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Nice University Hospital, Gerontology Department
name: Olivier GUERIN, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: