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

NCT04573829 | Completed

• 1 other identifier: 20-PP-19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavioral Disorder

Outcome Measures

Primary Outcomes (1)

• Ratio of personalised care projects completed

  at the end of 6 months

Study Arms (1)

Non-drug approaches at home

EXPERIMENTAL

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

Interventions

Home visit PROCEDURE

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

Non-drug approaches at home

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• Person involved during the motivational interviewing session regarding the psychoeducational program.
• Person who agreed and signed the informed consent.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead
• Fondation Mederic Alzheimer: collaborator

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

House Calls

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Olivier GUERIN, PU-PH

  Nice University Hospital, Gerontology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 5, 2020
• Study Start: January 14, 2021
• Primary Completion: March 31, 2022
• Study Completion: September 19, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)