Clinical trial NCT04820127: Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease: Impact on Health Resources Use
Official title: Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease and Related Disorders: Impact on Health Resources Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 668
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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.

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

Primary outcomes:
measure: patient's number of hospitalization at 18 months
timeFrame: From the inclusion until End of Study, 18 months
Secondary outcomes:
measure: patient's unscheduled hospitalization
timeFrame: From the inclusion until End of Study, 18 months
Other outcomes:
measure: Patient agitation symptoms severity
timeFrame: From the inclusion until End of Study, 18 months
measure: severity and frequency of others emergent psycho-behavioral symptoms
timeFrame: From the inclusion until End of Study, 18 months
measure: Number of psychotropic drug prescription for the patient
timeFrame: From the inclusion until End of Study, 18 months
measure: patient's quality of life
timeFrame: From the inclusion until End of Study, 18 months
measure: Patient's psycho-behavioral symptoms distress on the caregiver
timeFrame: From the inclusion until End of Study, 18 months
measure: caregiver's hospitalizations
timeFrame: From the inclusion until End of Study, 18 months
measure: caregiver's quality of life
timeFrame: From the inclusion until End of Study, 18 months
measure: Cost/efficiency ratio and cost /utility differential from the community perspective
timeFrame: From the inclusion until End of Study, 18 months
measure: Comparison between Standardized evaluation and personalized care program real cost
timeFrame: From the inclusion until End of Study, 18 months
measure: quantity and cost health system resources used by the patient
timeFrame: From the inclusion until End of Study, 18 months
measure: efficiency and cost from the community perspective.
timeFrame: From the inclusion until End of Study, 18 months
Locations:
city: Albi
country: France
facility: CH d'Albi
city: Cahors
country: France
facility: CH de Cahors
city: Carcassonne
country: France
facility: Carcassonne Hospital
city: Castres
country: France
facility: CHI Castres Mazamet
city: Lannemezan
country: France
facility: CH Lannemezan
city: Lavaur
country: France
facility: CH Lavaur
city: Limoges
country: France
facility: Limoges university hospital
city: Lyon
country: France
facility: Lyon University Hospital
city: Montauban
country: France
facility: CH Montauban
city: Narbonne
country: France
facility: Narbonne Hospital
city: Perpignan
country: France
facility: Perpignan Hospital
city: Saint Girons
country: France
facility: CHI Val d'Ariège
city: Toulouse
country: France
facility: Toulouse University Hospital (CHU de Toulouse)
city: Toulouse
country: France
facility: University Hospital Toulouse - Neurology department
city: Vic en Bigorre
country: France
facility: CH de Bigorre
city: Villefranche-sur-Saône
country: France
facility: HNO-Franche-sur-Soâne
Study officials:
affiliation: University Hospital Toulouse - Gerontopole
name: Maria SOTO, MD
role: PRINCIPAL_INVESTIGATOR
References: