Skip to main content
OpenTrials
Completed

NCT Number: NCT04820127

Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease: 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH d'Albi, Albi, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

personalized care preceded by a standardized assessment

Behavioral
  • 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 outcomes

  1. patient's number of hospitalization at 18 months

    Time frame: From the inclusion until End of Study, 18 months

    number of all causes hospitalization, either scheduled or unscheduled, including emergency department visits

Secondary outcomes

  1. patient's unscheduled hospitalization

    Time frame: From the inclusion until End of Study, 18 months

    all causes hospitalization, unscheduled, including emergency department visits

Other outcomes

  1. Patient agitation symptoms severity

    Time frame: From the inclusion until End of Study, 18 months

    assessed by Neuropsychiatric Inventory Clinician (NPI-C) scale based on the International Psychogeriatrics Association (IPA) (NPI-C-IPA) and Cohen-Mansfield Agitation Inventory (CMAI).

  2. severity and frequency of others emergent psycho-behavioral symptoms

    Time frame: From the inclusion until End of Study, 18 months

    assessed by the NPI scale

    Frequency (0-4) Severity (0-3): Caregiver Distress (0-5):

  3. Number of psychotropic drug prescription for the patient

    Time frame: From the inclusion until End of Study, 18 months

    prescription checked at each visit

  4. patient's quality of life

    Time frame: From the inclusion until End of Study, 18 months

    assessed by the Euro Quality of life (EQ-5D-5L) scale

  5. Patient's psycho-behavioral symptoms distress on the caregiver

    Time frame: From the inclusion until End of Study, 18 months

    "distress" score of the Neuropsychiatric Inventory-Clinician rating scale-IPA scale

    Frequency (0-4) Severity (0-3): Caregiver Distress (0-5):

  6. caregiver's hospitalizations

    Time frame: From the inclusion until End of Study, 18 months

    all causes of hospitalization, either scheduled or unscheduled, including emergency department visits

  7. caregiver's quality of life

    Time frame: From the inclusion until End of Study, 18 months

    assessed by the Euro Qol (EQ-5D-5L) scale

  8. Cost/efficiency ratio and cost /utility differential from the community perspective

    Time frame: From the inclusion until End of Study, 18 months

    Cost/efficiency ratio and cost /utility differential from the community perspective

  9. Comparison between Standardized evaluation and personalized care program real cost

    Time frame: From the inclusion until End of Study, 18 months

    micro-costing approach of health costs

  10. quantity and cost health system resources used by the patient

    Time frame: From the inclusion until End of Study, 18 months

    health system resources used by the patient quantity and cost in comparison with efficiency and cost from the community perspective.

  11. efficiency and cost from the community perspective.

    Time frame: From the inclusion until End of Study, 18 months

    health system resources used by the patient quantity and cost in comparison with efficiency and cost from the community perspective.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: PERSON-AL

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 29, 2021
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.