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

NCT04820127 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 668

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

Interventions

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;

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Maria SOTO, MD · University Hospital Toulouse - Gerontopole

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2026-04-28
Completion
2026-04-28

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04820127 on ClinicalTrials.gov