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

Alzheimer's Disease Clinical Trial

— PERSON-AL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04820127
• Other study ID #: RC31/19/0555
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2021
• Est. completion date: October 14, 2024

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: MARIA SOTO, MD
• Phone: 5 61 77 70 49
• Email: soto-martin.me[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 668
• Est. completion date: October 14, 2024
• Est. primary completion date: October 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Behavioral Symptoms

Intervention

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;

Locations

Country	Name	City	State
France	CH d'Albi	Albi
France	CH de Cahors	Cahors
France	Carcassonne Hospital	Carcassonne
France	CHI Castres Mazamet	Castres
France	CH Lannemezan	Lannemezan
France	CH Lavaur	Lavaur
France	Limoges university hospital	Limoges
France	Lyon University Hospital	Lyon
France	CH Montauban	Montauban
France	Narbonne Hospital	Narbonne
France	Perpignan Hospital	Perpignan
France	CHI Val d'Ariège	Saint Girons
France	Toulouse University Hospital (CHU de Toulouse)	Toulouse
France	University Hospital Toulouse - Neurology department	Toulouse
France	CH de Bigorre	Vic en Bigorre
France	HNO-Franche-sur-Soâne	Villefranche-sur-Saône

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Number of psychotropic drug prescription for the patient	prescription checked at each visit	From the inclusion until End of Study, 18 months
Other	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
Other	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
Other	caregiver's hospitalizations	all causes of hospitalization, either scheduled or unscheduled, including emergency department visits	From the inclusion until End of Study, 18 months
Other	caregiver's quality of life	assessed by the Euro Qol (EQ-5D-5L) scale	From the inclusion until End of Study, 18 months
Other	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
Other	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
Other	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
Other	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
Primary	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	patient's unscheduled hospitalization	all causes hospitalization, unscheduled, including emergency department visits	From the inclusion until End of Study, 18 months