NCT04820127Befejeződött
Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease: Impact on Health Resources Use
Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease and Related Disorders: Impact on Health Resources Use
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 8.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 668 (tényleges)
- Első benyújtás
- 2020. dec. 24.
- Kezdés
- 2021. okt. 14.
- Elsődleges befejezés
- 2026. ápr. 28.
- Fő szponzor
- University Hospital, Toulouse
- Betegségek
- Alzheimer-kór
- NCT-szám
- NCT04820127
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 668
- 2021. okt. 14. és az elsődleges befejezés (2026. ápr. 28.) között
- 15 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Agitation symptoms attributable either to other concomitant prescriptions, or to other psychiatric or evolving somatic diseases.
- Concomitant participation to any other interventional research study
Más betegség
- 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
Egyéb
- For the patient:
- Patient living in a residential care facility or having an institutionalization project within 6 months
- Patient under legal protection.
- For the caregiver:
- Caregiver under legal protection.
- Limited internet access or caregiver feeling unable to use it
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 60 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (15)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.