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

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04573829
Collaborator
Fondation Médéric Alzheimer (Other)
40
1
1
31.5
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Home visit
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
PsyDoMa :Non-drug Approaches at Home for Alzheimer's Patients With Psycho-behavioural Disorders and Psycho-education for the Caregivers
Actual Study Start Date :
Jan 14, 2021
Actual Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Ratio of personalised care projects completed [at the end of 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.).

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Nice Nice France 06000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice
  • Fondation Médéric Alzheimer

Investigators

  • Principal Investigator: Olivier GUERIN, PU-PH, Nice University Hospital, Gerontology Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT04573829
Other Study ID Numbers:
  • 20-PP-19
First Posted:
Oct 5, 2020
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2022