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

Frontotemporal Lobar Degeneration Clinical Trial

— DLFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03606798
• Other study ID #: CHUBX2015/06
• Status: Completed
• Phase: N/A
• Start date: June 21, 2018
• Est. completion date: October 6, 2021

Study information

• Verified date: March 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 6, 2021
• Est. primary completion date: October 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frontotemporal Lobar Degeneration
• Problem Behavior

Intervention

Other:
• 3 Home visits made by a psychologist
Patient and caregiver interviews with a psychologist at home

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychiatric Inventory (NPI)	Assessment of neuropsychiatric symptomatology	6 months
Secondary	Neuropsychiatric Inventory (NPI)	Assessment of neuropsychiatric symptomatology	12 months
Secondary	Mini Mental State Examination		6 months and 12 months
Secondary	Frontal Behavioral Inventory		6 months and 12 months
Secondary	Frontal Assessment Battery		6 months and 12 months
Secondary	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
Secondary	Sense of Competence Questionnaire (SCQ)		6 months and 12 months
Secondary	Quality of Life Questionnaire (QoL-AD)		6 months and 12 months
Secondary	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