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

Last updated: August 1, 2024
Sponsor: University Hospital, Toulouse
Overall Status: Active - Recruiting

Phase

N/A

Condition

Alzheimer's Disease

Dementia

Memory Loss

Treatment

personalized care preceded by a standardized assessment

Clinical Study ID

NCT04820127
RC31/19/0555
  • Ages > 60
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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, assumingmost 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 InternationalPsychogeriatric 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 responsiblehas 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 thequestionnaires and assess the patient.

  • Affiliated to French Healthcare System

Exclusion

Exclusion Criteria:

For the patient:

  • Agitation symptoms attributable either to other concomitant prescriptions, or toother psychiatric or evolving somatic diseases.

  • Patient living in a residential care facility or having an institutionalizationproject within 6 months

  • Patient with clinically significant or unstable disease that could affect he/herability to come for the study visit or complete the evaluations planned as perprotocol

  • 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

Study Design

Total Participants: 668
Treatment Group(s): 1
Primary Treatment: personalized care preceded by a standardized assessment
Phase:
Study Start date:
October 14, 2021
Estimated Completion Date:
October 14, 2024

Study Description

PERSON-AL is a multicentric, interventional, open-label, randomized, parallel-group, stratified by centre, study comparing two arms: usual care versus intervention (personalized care preceded by a standardized assessment)

Principal Objective : To evaluate the impact of a personalized intervention for the management of agitation due to psycho-behavioral symptoms on the use of scheduled and unscheduled hospitalizations at 18 months in patients with AD and related disorders.

Secondary Objectives:

A- To evaluate the impact of a personalized intervention at 18 months on:

For the patient:

  1. Unscheduled hospitalizations,

  2. Severity of agitation symptoms,

  3. The frequency and severity of emerging psycho-behavioral symptoms, other than agitation,

  4. Prescription of psychotropic drugs,

  5. Quality of life.

    For the caregiver:

  6. Distress related to psycho-behavioral symptoms,

  7. All causes hospitalizations,

  8. Quality of life.

B- Evaluate the medico-economic impact of this personalized intervention, and in particular:

  1. Its efficiency compared to usual management by means of cost-effectiveness and cost-utility analyses, from the community perspective and over a time horizon of 18 months,

  2. The actual cost of patient's standardized assessment and personalized management

  3. The use of care and associated costs for the caregiver and the efficiency of caregiver targeted intervention.

Connect with a study center

  • CH d'Albi

    Albi,
    France

    Active - Recruiting

  • CH de Cahors

    Cahors,
    France

    Active - Recruiting

  • Carcassonne Hospital

    Carcassonne, 11000
    France

    Active - Recruiting

  • CHI Castres Mazamet

    Castres,
    France

    Active - Recruiting

  • CH Lannemezan

    Lannemezan,
    France

    Active - Recruiting

  • CH Lavaur

    Lavaur,
    France

    Active - Recruiting

  • Limoges university hospital

    Limoges,
    France

    Active - Recruiting

  • Lyon University Hospital

    Lyon,
    France

    Active - Recruiting

  • CH Montauban

    Montauban,
    France

    Active - Recruiting

  • Narbonne Hospital

    Narbonne,
    France

    Site Not Available

  • Perpignan Hospital

    Perpignan,
    France

    Active - Recruiting

  • CHI Val d'Ariège

    Saint Girons,
    France

    Active - Recruiting

  • Toulouse University Hospital (CHU de Toulouse)

    Toulouse, 31059
    France

    Active - Recruiting

  • University Hospital Toulouse - Neurology department

    Toulouse, 31059
    France

    Active - Recruiting

  • CH de Bigorre

    Vic en Bigorre,
    France

    Active - Recruiting

  • HNO-Franche-sur-Soâne

    Villefranche-sur-Saône,
    France

    Site Not Available

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