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

Primary Purpose

Alzheimer's Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
personalized care preceded by a standardized assessment
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer's Disease

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH d'AlbiRecruiting
  • CH de CahorsRecruiting
  • Carcassonne HospitalRecruiting
  • CHI Castres MazametRecruiting
  • CH LannemezanRecruiting
  • CH LavaurRecruiting
  • Limoges university hospitalRecruiting
  • Lyon University HospitalRecruiting
  • CH MontaubanRecruiting
  • Narbonne Hospital
  • Perpignan HospitalRecruiting
  • CHI Val d'AriègeRecruiting
  • Toulouse University Hospital (CHU de Toulouse)Recruiting
  • University Hospital Toulouse - Neurology departmentRecruiting
  • CH de BigorreRecruiting
  • HNO-Franche-sur-Soâne

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control (usual care)

Intervention (personalized care program)

Arm Description

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).

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

Outcomes

Primary Outcome Measures

patient's number of hospitalization at 18 months
number of all causes hospitalization, either scheduled or unscheduled, including emergency department visits

Secondary Outcome Measures

patient's unscheduled hospitalization
all causes hospitalization, unscheduled, including emergency department visits

Full Information

First Posted
December 24, 2020
Last Updated
July 11, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT04820127
Brief Title
Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease: Impact on Health Resources Use
Acronym
PERSON-AL
Official Title
Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease and Related Disorders: Impact on Health Resources Use
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
October 14, 2024 (Anticipated)
Study Completion Date
October 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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: Unscheduled hospitalizations, Severity of agitation symptoms, The frequency and severity of emerging psycho-behavioral symptoms, other than agitation, Prescription of psychotropic drugs, Quality of life. For the caregiver: Distress related to psycho-behavioral symptoms, All causes hospitalizations, Quality of life. B- Evaluate the medico-economic impact of this personalized intervention, and in particular: 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, The actual cost of patient's standardized assessment and personalized management The use of care and associated costs for the caregiver and the efficiency of caregiver targeted intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
668 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control (usual care)
Arm Type
No Intervention
Arm Description
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).
Arm Title
Intervention (personalized care program)
Arm Type
Experimental
Arm Description
Patients in the intervention group will benefit from personalized care preceded by a standardized assessment
Intervention Type
Behavioral
Intervention Name(s)
personalized care preceded by a standardized assessment
Intervention Description
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;
Primary Outcome Measure Information:
Title
patient's number of hospitalization at 18 months
Description
number of all causes hospitalization, either scheduled or unscheduled, including emergency department visits
Time Frame
From the inclusion until End of Study, 18 months
Secondary Outcome Measure Information:
Title
patient's unscheduled hospitalization
Description
all causes hospitalization, unscheduled, including emergency department visits
Time Frame
From the inclusion until End of Study, 18 months
Other Pre-specified Outcome Measures:
Title
Patient agitation symptoms severity
Description
assessed by Neuropsychiatric Inventory Clinician (NPI-C) scale based on the International Psychogeriatrics Association (IPA) (NPI-C-IPA) and Cohen-Mansfield Agitation Inventory (CMAI).
Time Frame
From the inclusion until End of Study, 18 months
Title
severity and frequency of others emergent psycho-behavioral symptoms
Description
assessed by the NPI scale Frequency (0-4) Severity (0-3): Caregiver Distress (0-5):
Time Frame
From the inclusion until End of Study, 18 months
Title
Number of psychotropic drug prescription for the patient
Description
prescription checked at each visit
Time Frame
From the inclusion until End of Study, 18 months
Title
patient's quality of life
Description
assessed by the Euro Quality of life (EQ-5D-5L) scale
Time Frame
From the inclusion until End of Study, 18 months
Title
Patient's psycho-behavioral symptoms distress on the caregiver
Description
"distress" score of the Neuropsychiatric Inventory-Clinician rating scale-IPA scale Frequency (0-4) Severity (0-3): Caregiver Distress (0-5):
Time Frame
From the inclusion until End of Study, 18 months
Title
caregiver's hospitalizations
Description
all causes of hospitalization, either scheduled or unscheduled, including emergency department visits
Time Frame
From the inclusion until End of Study, 18 months
Title
caregiver's quality of life
Description
assessed by the Euro Qol (EQ-5D-5L) scale
Time Frame
From the inclusion until End of Study, 18 months
Title
Cost/efficiency ratio and cost /utility differential from the community perspective
Description
Cost/efficiency ratio and cost /utility differential from the community perspective
Time Frame
From the inclusion until End of Study, 18 months
Title
Comparison between Standardized evaluation and personalized care program real cost
Description
micro-costing approach of health costs
Time Frame
From the inclusion until End of Study, 18 months
Title
quantity and cost health system resources used by the patient
Description
health system resources used by the patient quantity and cost in comparison with efficiency and cost from the community perspective.
Time Frame
From the inclusion until End of Study, 18 months
Title
efficiency and cost from the community perspective.
Description
health system resources used by the patient quantity and cost in comparison with efficiency and cost from the community perspective.
Time Frame
From the inclusion until End of Study, 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARIA SOTO, MD
Phone
5 61 77 70 49
Ext
+33
Email
soto-martin.me@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie LESTIME
Phone
5 61 77 84 16
Ext
+33
Email
lestime.e@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria SOTO, MD
Organizational Affiliation
University Hospital Toulouse - Gerontopole
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH d'Albi
City
Albi
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carine CHIFFRE, MD
Phone
05 63 47 48 56
Ext
+33
Email
carine.chiffre@ch-albi.rss.fr
Facility Name
CH de Cahors
City
Cahors
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David DOMBROWSKI, MD
Phone
05 65 20 54 83
Ext
+33
Email
david.DOMBROWSKI@ch-cahors.fr
First Name & Middle Initial & Last Name & Degree
David DOMBROWSKI, MD
First Name & Middle Initial & Last Name & Degree
Inga COUFFIGNAL, MD
Facility Name
Carcassonne Hospital
City
Carcassonne
ZIP/Postal Code
11000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédérique NATHAN-BONNET, MD, PhD
First Name & Middle Initial & Last Name & Degree
Frédérique NATHAN-BONNET, MD, PhD
First Name & Middle Initial & Last Name & Degree
Anna BAKANOVA-KOUMOUVI, MD, PhD
Facility Name
CHI Castres Mazamet
City
Castres
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Noëlle Cufi, MD
Phone
05 63 71 62 91
Ext
+33
Email
mn-cufi@chic-cm.fr
First Name & Middle Initial & Last Name & Degree
Marie-Noëlle CUFI, MD
First Name & Middle Initial & Last Name & Degree
Amandine LEFORT, MD
Facility Name
CH Lannemezan
City
Lannemezan
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre SALLES, MD
First Name & Middle Initial & Last Name & Degree
Jean-Pierre SALLES, MD
First Name & Middle Initial & Last Name & Degree
Serge BORDES, MD
Facility Name
CH Lavaur
City
Lavaur
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Françoise DESCLAUX, MD
First Name & Middle Initial & Last Name & Degree
Françoise DESCLAUX, MD
First Name & Middle Initial & Last Name & Degree
Céline GUILLEMAUD, MD
Facility Name
Limoges university hospital
City
Limoges
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Achille TCHALLA, MD
First Name & Middle Initial & Last Name & Degree
Achille TCHALLA, MD
Facility Name
Lyon University Hospital
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre KROLAK-SALMON, MD
First Name & Middle Initial & Last Name & Degree
Pierre KROLAK-SALMON, MD
First Name & Middle Initial & Last Name & Degree
Julien VERNAUDON, MD
First Name & Middle Initial & Last Name & Degree
Alexis LEPETIT, MD
Facility Name
CH Montauban
City
Montauban
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélie Roustan, MD
Phone
05.63.92.81.31
Ext
+33
Email
a.roustan@ch-montauban.fr
Facility Name
Narbonne Hospital
City
Narbonne
Country
France
Individual Site Status
Withdrawn
Facility Name
Perpignan Hospital
City
Perpignan
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geneviève BARNIER-FIGUE, MD
First Name & Middle Initial & Last Name & Degree
Geneviève BARNIER-FIGUE, MD
Facility Name
CHI Val d'Ariège
City
Saint Girons
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lawrence Bories, MD
Phone
05 61 03 33 91
Email
l.bories@chi-val-ariege.fr
Facility Name
Toulouse University Hospital (CHU de Toulouse)
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria SOTO, MD, Ph D
Email
soto-martin.me@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Bruno VELLAS, MD, Ph D, Pr
First Name & Middle Initial & Last Name & Degree
Pierre-Jean OUSSET, MD, Ph D
First Name & Middle Initial & Last Name & Degree
Julien DELRIEU, MD, Ph D
First Name & Middle Initial & Last Name & Degree
Adélaïde DE MAULEON, MD, Ph D
First Name & Middle Initial & Last Name & Degree
Marion BAZIARD, MD, Ph D
First Name & Middle Initial & Last Name & Degree
Camille CRANSAC, MD, Ph D
First Name & Middle Initial & Last Name & Degree
Thierry VOISIN, MD, Ph D
First Name & Middle Initial & Last Name & Degree
Anne Bahia ABDELJALIL, MD, Ph D
First Name & Middle Initial & Last Name & Degree
Pascal SAIDLITZ, MD, Ph D
First Name & Middle Initial & Last Name & Degree
Françoise LALA, MD, Ph D
First Name & Middle Initial & Last Name & Degree
Nathalie SASTRE, MD, Ph D
First Name & Middle Initial & Last Name & Degree
Hélène VILLARS, MD, Ph D
Facility Name
University Hospital Toulouse - Neurology department
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérémy PARIENTE, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jérémy PARIENTE, MD, PhD
First Name & Middle Initial & Last Name & Degree
Marie RAFIQ, MD, PhD
First Name & Middle Initial & Last Name & Degree
Marie BENAITEAU, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jasmine CARLIER, MD, PhD
First Name & Middle Initial & Last Name & Degree
Camille TISSERAND, MD, PhD
Facility Name
CH de Bigorre
City
Vic en Bigorre
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yannick Gasnier, MD
Phone
05 62 54 70 15
Ext
+33
Email
ygasnier@ch-tarbes-vic.fr
Facility Name
HNO-Franche-sur-Soâne
City
Villefranche-sur-Saône
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JULIEN VERNAUDON, MD
Email
jvernaudon@hno.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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