PsyDoMa : Non-drug Approaches at Home for Alzheimer's Pat... | NCT04573829

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

NCT04573829

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Oct 7, 2022Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Behavioral Disorder

Interventions

Home visit

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2021Actual

Primary Completion Date

Mar 31, 2022Actual

Completion Date

Sep 19, 2022Actual

First Submitted Date

Sep 28, 2020

First Submission Date that Met QC Criteria

Oct 1, 2020

First Posted Date

Oct 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2022

Last Update Posted Date

Oct 7, 2022Actual

Name	Class
Fondation Mederic Alzheimer	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Home visit	Procedure	Psychologist come once a week for the carer and three times a week for the patient	Non-drug approaches at home

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

Eligibility Module

Eligibility Criteria

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.).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Olivier GUERIN, PU-PH	Nice University Hospital, Gerontology Department	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nice		Nice		06000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D011364	Professional Practice
D009934	Organization and Administration
D006298	Health Services Administration