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

• Status: Completed
• Conditions: Behavioral Disorder
• Intervention / Treatment: Procedure: Home visit

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Home visit; Psychologist come once a week for the carer and three times a week for the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ratio of personalised care projects completed	at the end of 6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Collaborators: Fondation Mederic Alzheimer
• Investigators: Principal Investigator: Olivier GUERIN, PU-PH, Nice University Hospital, Gerontology Department

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): September 19, 2022

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: 20-PP-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No