Multidisciplinary and Personalized Care of Behavioral Disorders in Frontotemporal Lobar Degeneration.

Study Overview
=================
Brief Summary
-----------------
Fronto-Temporal Lobar Degeneration (FTLD) refers to 3 categories of neurodegenerative diseases generally occurring between 55 and 65 years: Fronto-Temporal Dementia(FTD), Primary Progressive Aphasia (PPA), Semantic Dementia (SD). Clinical expression is substantially variable among individuals, but in most cases, behavioural disorders and personality changes are prominent. FTLD is poorly known by general public including health care professionals. Currently, the French health system does not meet the needs and expectations of patients and their families

Detailed Description
-----------------
Patients with FTLD and their caregivers need to be recognized and supported through specific and tailored made actions provided by expert teams. The main objective of our study is to evaluate the effectiveness of a 6-month personalized multidisciplinary care provided to the dyad FTLD patient and caregiver on patient's behavioural disorders. The secondary objectives are to assess the impact of this program on patient's cognitive deterioration, functional autonomy and behavioral problems, as well as caregiver's depressive symptomatology and sense of competence

Official Title
-----------------
Multidisciplinary and Personalized Care of Behavioral Disorders in Frontotemporal Lobar Degeneration.

Conditions
-----------------
Frontotemporal Lobar Degeneration

Intervention / Treatment
-----------------
* Other: 3 Home visits made by a psychologist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients Fronto-Temporal Lobar Degeneration diagnoses Men or women aged 18 and over Caregiver • Spouse, brother, sister, child living at patient's home and can provide the medical team of reliable information on the status of their parent. Exclusion criteria : Patient Patient institutionalized Pregnant or breast-feeding woman Psychotic syndrome Severe and unstable general medical condition Patient bedridden Caregiver Persons under legal protection Severe and unstable general medical condition Pregnant or breast-feeding woman

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multidisciplinary and personalized care<br>Personalized care and proposals bring by a team of experts : neurologists ; geriatrician ; psychologist. | Other: 3 Home visits made by a psychologist<br>* Patient and caregiver interviews with a psychologist at home<br>|
| No Intervention: Reference care<br>Standard clinical evaluations of patient with Frontotemporal Lobar Degeneration. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychiatric Inventory (NPI) | Assessment of neuropsychiatric symptomatology | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychiatric Inventory (NPI) | Assessment of neuropsychiatric symptomatology | 12 months | 
| Mini Mental State Examination |  | 6 months and 12 months | 
| Frontal Behavioral Inventory |  | 6 months and 12 months | 
| Frontal Assessment Battery |  | 6 months and 12 months | 
| Geriatric Depression Scale Score ( From 0 to 30) | Score : 0 - 5 : normal Score : 5 - 9 : light depression Score : 10 - 30 : severe depression | 6 months and 12 months | 
| Sense of Competence Questionnaire (SCQ) |  | 6 months and 12 months | 
| Quality of Life Questionnaire (QoL-AD) |  | 6 months and 12 months | 
| Hierarchical scale of internality for elderly people (EHIPA) score ( From 0 to 22) | The score varies from 0 to 22. A high score corresponding to an important internality | 6 months and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Frontotemporal Lobar Degeneration, Behavioral disorders