Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease and Related Disorders: Impact on Health Resources Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 668
- 试验地点
- 31
- 主要终点
- patient's number of hospitalization at 18 months
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control (usual care)
Patients in the control group will benefit from the usual care with a half-yearly visit by the specialist physician (geriatrician, neurologist or psychiatrist) according to AD French national management guidelines (HAS 2011 and HAS 2018).
Intervention (personalized care program)
Patients in the intervention group will benefit from personalized care preceded by a standardized assessment
干预措施: personalized care preceded by a standardized assessment (Behavioral)
结局指标
主要结局
patient's number of hospitalization at 18 months
时间窗: From the inclusion until End of Study, 18 months
number of all causes hospitalization, either scheduled or unscheduled, including emergency department visits
次要结局
- patient's unscheduled hospitalization(From the inclusion until End of Study, 18 months)