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

NCT04820127 | Completed

• 1 other identifier: RC31/19/0555
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• patient's number of hospitalization at 18 months

  number of all causes hospitalization, either scheduled or unscheduled, including emergency department visits

  From the inclusion until End of Study, 18 months

Secondary Outcomes (1)

• patient's unscheduled hospitalization

  From the inclusion until End of Study, 18 months

Other Outcomes (11)

• Patient agitation symptoms severity

  From the inclusion until End of Study, 18 months

• severity and frequency of others emergent psycho-behavioral symptoms

  From the inclusion until End of Study, 18 months

• Number of psychotropic drug prescription for the patient

  From the inclusion until End of Study, 18 months

Study Arms (2)

Control (usual care)

NO INTERVENTION

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).

Intervention (personalized care program)

EXPERIMENTAL

Patients in the intervention group will benefit from personalized care preceded by a standardized assessment

Behavioral: personalized care preceded by a standardized assessment

Interventions

personalized care preceded by a standardized assessment BEHAVIORAL

* personalized intervention plan (PIP) proposed to the patient/caregiver dyad to correct potentially reversible causes of psycho-behavioral symptoms. This PIP will be re-evaluated and adapted at each visit by the nurse in close collaboration with the GP; * PIP implementation will be based on a close follow-up during the 18 months follow-up coordinated by the nurse (3 memory consultation visits, 3 home visits (with the GP) and 6 phone calls). This follow up will be enhanced with the use of a web platform (allowing teleconsultation, tele-expertise and telemonitoring); * specific training on psycho-behavioral symptoms for caregivers at baseline and during follow-up will be performed. On line training on psycho-behavioral symptoms management for GP will be available;

Intervention (personalized care program)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• For the patient:
• Agitation symptoms attributable either to other concomitant prescriptions, or to other psychiatric or evolving somatic diseases.
• Patient living in a residential care facility or having an institutionalization project within 6 months
• Patient with clinically significant or unstable disease that could affect he/her ability to come for the study visit or complete the evaluations planned as per protocol
• Concomitant participation to any other interventional research study
• Patient under legal protection.
• For the caregiver:
• Caregiver under legal protection.
• Limited internet access or caregiver feeling unable to use it

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (15)

CH d'Albi

Albi, France

Location

CH de Cahors

Cahors, France

Location

Carcassonne Hospital

Carcassonne, 11000, France

Location

CHI Castres Mazamet

Castres, France

Location

CH Lannemezan

Lannemezan, France

Location

CH Lavaur

Lavaur, France

Location

Limoges university hospital

Limoges, France

Location

Lyon University Hospital

Lyon, France

Location

CH Montauban

Montauban, France

Location

Perpignan Hospital

Perpignan, France

Location

CHI Val d'Ariège

Saint-Girons, France

Location

Toulouse University Hospital (CHU de Toulouse)

Toulouse, 31059, France

Location

University Hospital Toulouse - Neurology department

Toulouse, 31059, France

Location

CH de Bigorre

Vic-en-Bigorre, France

Location

HNO-Franche-sur-Soâne

Villefranche-sur-Saône, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Maria SOTO, MD

  University Hospital Toulouse - Gerontopole

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: March 29, 2021
• Study Start: October 14, 2021
• Primary Completion: April 28, 2026
• Study Completion: April 28, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15)