Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease: Impact on Health Resources Use
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Alzheimer's Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 60 years and 125 years
- Gender
- Both males and females
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 fo...
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.
Tracking Information
- NCT #
- NCT04820127
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Maria SOTO, MD University Hospital Toulouse - Gerontopole