Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease: Impact on Health Resources Use
NCT ID: NCT04820127
Last Updated: 2024-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
668 participants
INTERVENTIONAL
2021-10-14
2024-10-14
Brief Summary
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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.
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Detailed Description
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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:
1. Unscheduled hospitalizations,
2. Severity of agitation symptoms,
3. The frequency and severity of emerging psycho-behavioral symptoms, other than agitation,
4. Prescription of psychotropic drugs,
5. Quality of life.
For the caregiver:
6. Distress related to psycho-behavioral symptoms,
7. All causes hospitalizations,
8. Quality of life.
B- Evaluate the medico-economic impact of this personalized intervention, and in particular:
1. Its efficiency compared to usual management by means of cost-effectiveness and cost-utility analyses, from the community perspective and over a time horizon of 18 months,
2. The actual cost of patient's standardized assessment and personalized management
3. The use of care and associated costs for the caregiver and the efficiency of caregiver targeted intervention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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).
No interventions assigned to this group
Intervention (personalized care program)
Patients in the intervention group will benefit from personalized care preceded by a standardized assessment
personalized care preceded by a standardized assessment
* personalized intervention plan (PIP) proposed to the patient/caregiver dyad to correct potentially reversible causes of psycho-behavioral symptoms. This PIP will be re-evaluated and adapted at each visit by the nurse in close collaboration with the GP;
* PIP implementation will be based on a close follow-up during the 18 months follow-up coordinated by the nurse (3 memory consultation visits, 3 home visits (with the GP) and 6 phone calls). This follow up will be enhanced with the use of a web platform (allowing teleconsultation, tele-expertise and telemonitoring);
* specific training on psycho-behavioral symptoms for caregivers at baseline and during follow-up will be performed. On line training on psycho-behavioral symptoms management for GP will be available;
Interventions
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personalized care preceded by a standardized assessment
* personalized intervention plan (PIP) proposed to the patient/caregiver dyad to correct potentially reversible causes of psycho-behavioral symptoms. This PIP will be re-evaluated and adapted at each visit by the nurse in close collaboration with the GP;
* PIP implementation will be based on a close follow-up during the 18 months follow-up coordinated by the nurse (3 memory consultation visits, 3 home visits (with the GP) and 6 phone calls). This follow up will be enhanced with the use of a web platform (allowing teleconsultation, tele-expertise and telemonitoring);
* specific training on psycho-behavioral symptoms for caregivers at baseline and during follow-up will be performed. On line training on psycho-behavioral symptoms management for GP will be available;
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Maria SOTO, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Toulouse - Gerontopole
Locations
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CH d'Albi
Albi, , France
CH de Cahors
Cahors, , France
Carcassonne Hospital
Carcassonne, , France
CHI Castres Mazamet
Castres, , France
CH Lannemezan
Lannemezan, , France
CH Lavaur
Lavaur, , France
Limoges university hospital
Limoges, , France
Lyon University Hospital
Lyon, , France
CH Montauban
Montauban, , France
Narbonne Hospital
Narbonne, , France
Perpignan Hospital
Perpignan, , France
CHI Val d'Ariège
Saint-Girons, , France
Toulouse University Hospital (CHU de Toulouse)
Toulouse, , France
University Hospital Toulouse - Neurology department
Toulouse, , France
CH de Bigorre
Vic-en-Bigorre, , France
HNO-Franche-sur-Soâne
Villefranche-sur-Saône, , France
Countries
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Central Contacts
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Facility Contacts
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Frédérique NATHAN-BONNET, MD, PhD
Role: primary
Jean-Pierre SALLES, MD
Role: primary
Françoise DESCLAUX, MD
Role: primary
Achille TCHALLA, MD
Role: primary
Pierre KROLAK-SALMON, MD
Role: primary
Geneviève BARNIER-FIGUE, MD
Role: primary
Jérémy PARIENTE, MD, PhD
Role: primary
Other Identifiers
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RC31/19/0555
Identifier Type: -
Identifier Source: org_study_id
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