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

Behavioral Disorder Clinical Trial

— PSYDOMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04573829
• Other study ID #: 20-PP-19
• Status: Completed
• Phase: N/A
• Start date: January 14, 2021
• Est. completion date: September 19, 2022

Study information

• Verified date: October 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 19, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Behavioral Disorder
• Disease

Intervention

Procedure:
• Home visit
Psychologist come once a week for the carer and three times a week for the patient

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice	Fondation Médéric Alzheimer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of personalised care projects completed		at the end of 6 months