Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease: Impact on Health Re… (NCT04820127) | Clinical Trial Compass
CompletedNot Applicable
Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease: Impact on Health Resources Use
France668 participantsStarted 2021-10-14
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
patient's number of hospitalization at 18 months
Timeframe: From the inclusion until End of Study, 18 months