Clinical trial NCT03606798: Multidisciplinary and Personalized Care of Behavioral Disorders in Frontotemporal Lobar Degeneration.
Official title: Multidisciplinary and Personalized Care of Behavioral Disorders in Frontotemporal Lobar Degeneration.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frontotemporal Lobar Degeneration
Keywords: Frontotemporal Lobar Degeneration
Behavioral disorders
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: Neuropsychiatric Inventory (NPI)
timeFrame: 6 months
Secondary outcomes:
measure: Neuropsychiatric Inventory (NPI)
timeFrame: 12 months
measure: Mini Mental State Examination
timeFrame: 6 months and 12 months
measure: Frontal Behavioral Inventory
timeFrame: 6 months and 12 months
measure: Frontal Assessment Battery
timeFrame: 6 months and 12 months
measure: Geriatric Depression Scale Score ( From 0 to 30)
timeFrame: 6 months and 12 months
measure: Sense of Competence Questionnaire (SCQ)
timeFrame: 6 months and 12 months
measure: Quality of Life Questionnaire (QoL-AD)
timeFrame: 6 months and 12 months
measure: Hierarchical scale of internality for elderly people (EHIPA) score ( From 0 to 22)
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Jean-François DARTIGUES
role: PRINCIPAL_INVESTIGATOR
References: