Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease and Related Disorders: Impact on Health Resources Use

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The present project propose to study the effectiveness of a personalized care management of psycho-behavioral symptoms based on an evidence-based standardized assessment to identify and understand the underlying causes of psycho-behavioral symptoms followed by a personalized intervention based on targeted and prioritized actions. This personalized intervention is proposed both to Alzheimer disease (AD) patients living at home with agitation-type psycho-behavioral symptoms, and also to their caregivers with the support and coordination of a nurse working in collaboration with the specialist physician and the General Practitioner (GP). News technologies are used to enhance the follow-up, based on telehealth, and caregiver training. The project hypothesize that, for a vulnerable population at risk (AD patient with agitation and their caregivers) living at home, a personalized intervention, carried out and coordinated by a nurse in close collaboration with the specialist and GP, would reduce hospitalizations and have a positive effect on the disease evolution and caregiver distress. Also this personalized intervention could reduce the cost of care, in particular by reducing the costs associated with hospitalizations and informal help.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

⁃ For the patient :

• Diagnosed with major neuro-cognitive disorders (DSM V) at all severity stages.

• Leaving at home

• Assisted by a caregiver, from patient's family or personal environment, assuming most of patient care (spending at least 6 hours per week with the patient)

• caregiver available to come with the patient to study visits as planned per protocol

• existing agitation since at least one month (according to International Psychogeriatric Association (IPA) criteria)

• agitation severity ≥ 2 , based on Clinician Global Impression of Severity (CGI-S) (at least mild severity)

• the patient, his/her family member/trusted person , or his /her legal responsible has provided written informed consent to participate in the study

• referring physician's oral approval obtained for patient participation in the study

• Affiliated to French Healthcare System

⁃ For the caregiver:

• Has provided his/her written informed consent to participate in the study

• Ability to understand and speak French properly, ability to complete the questionnaires and assess the patient.

• Affiliated to French Healthcare System

Locations
Other Locations
France
CH d'Albi
RECRUITING
Albi
CH de Cahors
RECRUITING
Cahors
Carcassonne Hospital
RECRUITING
Carcassonne
CHI Castres Mazamet
RECRUITING
Castres
CH Lannemezan
RECRUITING
Lannemezan
CH Lavaur
RECRUITING
Lavaur
Limoges university hospital
RECRUITING
Limoges
Lyon University Hospital
RECRUITING
Lyon
CH Montauban
RECRUITING
Montauban
Narbonne Hospital
WITHDRAWN
Narbonne
Perpignan Hospital
RECRUITING
Perpignan
CHI Val d'Ariège
RECRUITING
Saint-girons
Toulouse University Hospital (CHU de Toulouse)
RECRUITING
Toulouse
University Hospital Toulouse - Neurology department
RECRUITING
Toulouse
CH de Bigorre
RECRUITING
Vic-en-bigorre
HNO-Franche-sur-Soâne
NOT_YET_RECRUITING
Villefranche-sur-saône
Contact Information
Primary
MARIA SOTO, MD
soto-martin.me@chu-toulouse.fr
5 61 77 70 49
Backup
Elodie LESTIME
lestime.e@chu-toulouse.fr
5 61 77 84 16
Time Frame
Start Date: 2021-10-14
Estimated Completion Date: 2024-10-14
Participants
Target number of participants: 668
Treatments
No_intervention: Control (usual care)
Patients in the control group will benefit from the usual care with a half-yearly visit by the specialist physician (geriatrician, neurologist or psychiatrist) according to AD French national management guidelines (HAS 2011 and HAS 2018).
Experimental: Intervention (personalized care program)
Patients in the intervention group will benefit from personalized care preceded by a standardized assessment
Authors
Nicolas BOUDET
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov