NCT04820127Completed
Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease: Impact on Health Resources Use
Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease and Related Disorders: Impact on Health Resources Use
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 668 (actual)
- First submitted
- 24 Dec 2020
- Start date
- 14 Oct 2021
- Primary completion date
- 28 Apr 2026
- Lead sponsor
- University Hospital, Toulouse
- Diseases
- Alzheimer disease
- NCT number
- NCT04820127
What you commit to
- Study type: Interventional
- Participants enrolled: 668
- From 14 Oct 2021 to the primary completion date, 28 Apr 2026
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Agitation symptoms attributable either to other concomitant prescriptions, or to other psychiatric or evolving somatic diseases.
- Concomitant participation to any other interventional research study
Other illness
- 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
Other
- For the patient:
- Patient living in a residential care facility or having an institutionalization project within 6 months
- Patient under legal protection.
- For the caregiver:
- Caregiver under legal protection.
- Limited internet access or caregiver feeling unable to use it
Who the study is looking for
- 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
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CH d'Albi Coordinator of this site? Confirm its status | Albi | France | Unknown status |
| CH de Cahors Coordinator of this site? Confirm its status | Cahors | France | Unknown status |
| Carcassonne Hospital Coordinator of this site? Confirm its status | Carcassonne | France | Unknown status |
| CHI Castres Mazamet Coordinator of this site? Confirm its status | Castres | France | Unknown status |
| CH Lannemezan Coordinator of this site? Confirm its status | Lannemezan | France | Unknown status |
| CH Lavaur Coordinator of this site? Confirm its status | Lavaur | France | Unknown status |
| Limoges university hospital Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| Lyon University Hospital Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| CH Montauban Coordinator of this site? Confirm its status | Montauban | France | Unknown status |
| Perpignan Hospital Coordinator of this site? Confirm its status | Perpignan | France | Unknown status |
| CHI Val d'Ariège Coordinator of this site? Confirm its status | Saint-Girons | France | Unknown status |
| University Hospital Toulouse - Neurology department Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Toulouse University Hospital (CHU de Toulouse) Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| CH de Bigorre Coordinator of this site? Confirm its status | Vic-en-Bigorre | France | Unknown status |
| HNO-Franche-sur-Soâne Coordinator of this site? Confirm its status | Villefranche-sur-Saône | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.