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

Toulouse University Hospital

Status: Enrolling

Conditions: Alzheimer's Disease

Treatments: Behavioral: personalized care preceded by a standardized assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT04820127

RC31/19/0555

Details and patient eligibility

About

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.

Full 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.

Enrollment: 668 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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668 participants in 2 patient groups

Control (usual care)

No Intervention group

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).

Intervention (personalized care program)

Experimental group

Description:

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

Treatment:

Behavioral: personalized care preceded by a standardized assessment