Personalized care for managing agitation in Alzheimer's patients
Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease and Related Disorders: Impact on Health Resources Use
This study is testing if personalized care plans can help reduce agitation and improve quality of life for people with Alzheimer's living at home, compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 668 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 16 sites (Albi and 15 other locations) |
| Trial ID | NCT04820127 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of personalized care management for psycho-behavioral symptoms in Alzheimer's Disease patients living at home. It involves a standardized assessment to identify the underlying causes of agitation, followed by tailored interventions coordinated by a nurse in collaboration with a specialist physician and the patient's general practitioner. The study compares usual care with this personalized approach over 18 months, focusing on hospitalizations, symptom severity, and quality of life for both patients and caregivers. Telehealth technologies will be utilized to enhance follow-up and caregiver training.
Who should consider this trial
Good fit: Ideal candidates include Alzheimer's patients living at home with agitation symptoms and their caregivers who provide substantial support.
Not a fit: Patients without agitation symptoms or those not living at home may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could significantly reduce hospitalizations and improve the quality of life for Alzheimer's patients and their caregivers.
How similar studies have performed: Other studies have shown promise in personalized interventions for managing behavioral symptoms in dementia, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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
Where this trial is running
Albi and 15 other locations
- CH d'Albi — Albi, France (Recruiting)
- CH de Cahors — Cahors, France (Recruiting)
- Carcassonne Hospital — Carcassonne, France (Recruiting)
- CHI Castres Mazamet — Castres, France (Recruiting)
- CH Lannemezan — Lannemezan, France (Recruiting)
- CH Lavaur — Lavaur, France (Recruiting)
- Limoges university hospital — Limoges, France (Recruiting)
- Lyon University Hospital — Lyon, France (Recruiting)
- CH Montauban — Montauban, France (Recruiting)
- Narbonne Hospital — Narbonne, France (Withdrawn)
- Perpignan Hospital — Perpignan, France (Recruiting)
- CHI Val d'Ariège — Saint Girons, France (Recruiting)
- Toulouse University Hospital (CHU de Toulouse) — Toulouse, France (Recruiting)
- University Hospital Toulouse - Neurology department — Toulouse, France (Recruiting)
- CH de Bigorre — Vic en Bigorre, France (Recruiting)
- HNO-Franche-sur-Soâne — Villefranche-sur-Saône, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Maria SOTO, MD — University Hospital Toulouse - Gerontopole
- Study coordinator: Maria Soto, Md
- Email: soto-martin.me@chu-toulouse.fr
- Phone: 5 61 77 70 49
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.