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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Behavioral: personalized care preceded by a standardized assessment

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 668
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MARIA SOTO, MD; Phone Number: +33 5 61 77 70 49; Email: soto-martin.me@chu-toulouse.fr
• Study Contact Backup: Name: Elodie LESTIME; Phone Number: +33 5 61 77 84 16; Email: lestime.e@chu-toulouse.fr

Study Locations

• France
  • Albi, France
    • Recruiting
    • CH d'Albi
    • Contact: Carine CHIFFRE, MD; Phone Number: +33 05 63 47 48 56; Email: carine.chiffre@ch-albi.rss.fr
  • Cahors, France
    • Recruiting
    • CH de Cahors
    • Contact: David DOMBROWSKI, MD; Phone Number: +33 05 65 20 54 83; Email: david.DOMBROWSKI@ch-cahors.fr
    • Principal Investigator: David DOMBROWSKI, MD
    • Sub-Investigator: Inga COUFFIGNAL, MD
  • Carcassonne, France, 11000
    • Recruiting
    • Carcassonne Hospital
    • Contact: Frédérique NATHAN-BONNET, MD, PhD
    • Principal Investigator: Frédérique NATHAN-BONNET, MD, PhD
    • Sub-Investigator: Anna BAKANOVA-KOUMOUVI, MD, PhD
  • Castres, France
    • Recruiting
    • CHI Castres Mazamet
    • Contact: Marie-Noëlle Cufi, MD; Phone Number: +33 05 63 71 62 91; Email: mn-cufi@chic-cm.fr
    • Principal Investigator: Marie-Noëlle CUFI, MD
    • Sub-Investigator: Amandine LEFORT, MD
  • Lannemezan, France
    • Recruiting
    • CH Lannemezan
    • Contact: Jean-Pierre SALLES, MD
    • Principal Investigator: Jean-Pierre SALLES, MD
    • Sub-Investigator: Serge BORDES, MD
  • Lavaur, France
    • Recruiting
    • CH Lavaur
    • Contact: Françoise DESCLAUX, MD
    • Principal Investigator: Françoise DESCLAUX, MD
    • Sub-Investigator: Céline GUILLEMAUD, MD
  • Limoges, France
    • Recruiting
    • Limoges university hospital
    • Contact: Achille TCHALLA, MD
    • Principal Investigator: Achille TCHALLA, MD
  • Lyon, France
    • Recruiting
    • Lyon university hospital
    • Contact: Pierre KROLAK-SALMON, MD
    • Principal Investigator: Pierre KROLAK-SALMON, MD
    • Sub-Investigator: Julien VERNAUDON, MD
    • Sub-Investigator: Alexis LEPETIT, MD
  • Montauban, France
    • Recruiting
    • CH Montauban
    • Contact: Aurélie Roustan, MD; Phone Number: +33 05.63.92.81.31; Email: a.roustan@ch-montauban.fr
  • Narbonne, France
    • Withdrawn
    • Narbonne Hospital
  • Perpignan, France
    • Recruiting
    • Perpignan Hospital
    • Contact: Geneviève BARNIER-FIGUE, MD
    • Principal Investigator: Geneviève BARNIER-FIGUE, MD
  • Saint Girons, France
    • Recruiting
    • CHI Val d'Ariège
    • Contact: Lawrence Bories, MD; Phone Number: 05 61 03 33 91; Email: l.bories@chi-val-ariege.fr
  • Toulouse, France, 31059
    • Recruiting
    • Toulouse University Hospital (CHU de Toulouse)
    • Contact: Maria SOTO, MD, Ph D; Email: soto-martin.me@chu-toulouse.fr
    • Sub-Investigator: Bruno VELLAS, MD, Ph D, Pr
    • Sub-Investigator: Pierre-Jean OUSSET, MD, Ph D
    • Sub-Investigator: Julien DELRIEU, MD, Ph D
    • Sub-Investigator: Adélaïde DE MAULEON, MD, Ph D
    • Sub-Investigator: Marion BAZIARD, MD, Ph D
    • Sub-Investigator: Camille CRANSAC, MD, Ph D
    • Sub-Investigator: Thierry VOISIN, MD, Ph D
    • Sub-Investigator: Anne Bahia ABDELJALIL, MD, Ph D
    • Sub-Investigator: Pascal SAIDLITZ, MD, Ph D
    • Sub-Investigator: Françoise LALA, MD, Ph D
    • Sub-Investigator: Nathalie SASTRE, MD, Ph D
    • Sub-Investigator: Hélène VILLARS, MD, Ph D
  • Toulouse, France, 31059
    • Recruiting
    • University Hospital Toulouse - Neurology department
    • Contact: Jérémy PARIENTE, MD, PhD
    • Principal Investigator: Jérémy PARIENTE, MD, PhD
    • Sub-Investigator: Marie RAFIQ, MD, PhD
    • Sub-Investigator: Marie BENAITEAU, MD, PhD
    • Sub-Investigator: Jasmine CARLIER, MD, PhD
    • Sub-Investigator: Camille TISSERAND, MD, PhD
  • Vic en Bigorre, France
    • Recruiting
    • CH de Bigorre
    • Contact: Yannick Gasnier, MD; Phone Number: +33 05 62 54 70 15; Email: ygasnier@ch-tarbes-vic.fr
  • Villefranche-sur-Saône, France
    • Not yet recruiting
    • HNO-Franche-sur-Soâne
    • Contact: JULIEN VERNAUDON, MD; Email: jvernaudon@hno.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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, 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: personalized care preceded by a standardized assessment; 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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient's unscheduled hospitalization	all causes hospitalization, unscheduled, including emergency department visits	From the inclusion until End of Study, 18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient agitation symptoms severity	assessed by Neuropsychiatric Inventory Clinician (NPI-C) scale based on the International Psychogeriatrics Association (IPA) (NPI-C-IPA) and Cohen-Mansfield Agitation Inventory (CMAI).	From the inclusion until End of Study, 18 months
severity and frequency of others emergent psycho-behavioral symptoms	assessed by the NPI scale Frequency (0-4) Severity (0-3): Caregiver Distress (0-5):	From the inclusion until End of Study, 18 months
Number of psychotropic drug prescription for the patient	prescription checked at each visit	From the inclusion until End of Study, 18 months
patient's quality of life	assessed by the Euro Quality of life (EQ-5D-5L) scale	From the inclusion until End of Study, 18 months
Patient's psycho-behavioral symptoms distress on the caregiver	"distress" score of the Neuropsychiatric Inventory-Clinician rating scale-IPA scale Frequency (0-4) Severity (0-3): Caregiver Distress (0-5):	From the inclusion until End of Study, 18 months
caregiver's hospitalizations	all causes of hospitalization, either scheduled or unscheduled, including emergency department visits	From the inclusion until End of Study, 18 months
caregiver's quality of life	assessed by the Euro Qol (EQ-5D-5L) scale	From the inclusion until End of Study, 18 months
Cost/efficiency ratio and cost /utility differential from the community perspective	Cost/efficiency ratio and cost /utility differential from the community perspective	From the inclusion until End of Study, 18 months
Comparison between Standardized evaluation and personalized care program real cost	micro-costing approach of health costs	From the inclusion until End of Study, 18 months
quantity and cost health system resources used by the patient	health system resources used by the patient quantity and cost in comparison with efficiency and cost from the community perspective.	From the inclusion until End of Study, 18 months
efficiency and cost from the community perspective.	health system resources used by the patient quantity and cost in comparison with efficiency and cost from the community perspective.	From the inclusion until End of Study, 18 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Maria SOTO, MD, University Hospital Toulouse - Gerontopole

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Estimated): October 14, 2024
• Study Completion (Estimated): October 14, 2024

Study Registration Dates

• First Submitted: December 24, 2020
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Behavioral Symptoms
• Other Study ID Numbers: RC31/19/0555

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No