Status:
RECRUITING
Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease: Impact on Health Resources Use
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
60+ years
Phase:
NA
Brief 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...
Detailed 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 sta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 14 2024
Estimated Enrollment :
668 Patients enrolled
Trial Details
Trial ID
NCT04820127
Start Date
October 14 2021
End Date
October 14 2024
Last Update
August 2 2024
Active Locations (16)
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1
CH d'Albi
Albi, France
2
CH de Cahors
Cahors, France
3
Carcassonne Hospital
Carcassonne, France, 11000
4
CHI Castres Mazamet
Castres, France