Completed

NCT Number: NCT04573829

PsyDoMa : Non-drug Approaches at Home for Alzheimer's Patients With Psycho-behavioural Disorders

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.

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Key information

Conditions

Behavioral Disorder Mental Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Home visit

Procedure

Psychologist come once a week for the carer and three times a week for the patient

Primary outcomes

Ratio of personalised care projects completed

Time frame: at the end of 6 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Collaborators

Fondation Mederic Alzheimer

Registry information

Official study title

PsyDoMa :Non-drug Approaches at Home for Alzheimer's Patients With Psycho-behavioural Disorders and Psycho-education for the Caregivers

Acronym: PSYDOMA

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Oct 5, 2020
Registry last updated: Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed