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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
668
* 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;
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
Perpignan Hospital
Perpignan, France
...and 5 more locations
patient's number of hospitalization at 18 months
number of all causes hospitalization, either scheduled or unscheduled, including emergency department visits
Time frame: From the inclusion until End of Study, 18 months
patient's unscheduled hospitalization
all causes hospitalization, unscheduled, including emergency department visits
Time frame: From the inclusion until End of Study, 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.