Back to resultsMultidisciplinary and Personalized Care of Behavioral Disorders in Frontotemporal Lobar Degeneration. (DLFT)
Primary Purpose
Frontotemporal Lobar Degeneration
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
3 Home visits made by a psychologist
Sponsored by
About this trial
This is an interventional supportive care trial for Frontotemporal Lobar Degeneration focused on measuring Frontotemporal Lobar Degeneration, Behavioral disorders
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
Sites / Locations
- Bordeaux University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Multidisciplinary and personalized care
Reference care
Arm Description
Personalized care and proposals bring by a team of experts : neurologists ; geriatrician ; psychologist.
Standard clinical evaluations of patient with Frontotemporal Lobar Degeneration.
Outcomes
Primary Outcome Measures
Neuropsychiatric Inventory (NPI)
Assessment of neuropsychiatric symptomatology
Secondary Outcome Measures
Neuropsychiatric Inventory (NPI)
Assessment of neuropsychiatric symptomatology
Mini Mental State Examination
Frontal Behavioral Inventory
Frontal Assessment Battery
Geriatric Depression Scale Score ( From 0 to 30)
Score : 0 - 5 : normal Score : 5 - 9 : light depression Score : 10 - 30 : severe depression
Sense of Competence Questionnaire (SCQ)
Quality of Life Questionnaire (QoL-AD)
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
Full Information
NCT ID
NCT03606798
First Posted
July 20, 2018
Last Updated
March 30, 2022
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT03606798
Brief Title
Multidisciplinary and Personalized Care of Behavioral Disorders in Frontotemporal Lobar Degeneration.
Acronym
DLFT
Official Title
Multidisciplinary and Personalized Care of Behavioral Disorders in Frontotemporal Lobar Degeneration.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
October 6, 2021 (Actual)
Study Completion Date
October 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frontotemporal Lobar Degeneration
Keywords
Frontotemporal Lobar Degeneration, Behavioral disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multidisciplinary and personalized care
Arm Type
Experimental
Arm Description
Personalized care and proposals bring by a team of experts : neurologists ; geriatrician ; psychologist.
Arm Title
Reference care
Arm Type
No Intervention
Arm Description
Standard clinical evaluations of patient with Frontotemporal Lobar Degeneration.
Intervention Type
Other
Intervention Name(s)
3 Home visits made by a psychologist
Intervention Description
Patient and caregiver interviews with a psychologist at home
Primary Outcome Measure Information:
Title
Neuropsychiatric Inventory (NPI)
Description
Assessment of neuropsychiatric symptomatology
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Neuropsychiatric Inventory (NPI)
Description
Assessment of neuropsychiatric symptomatology
Time Frame
12 months
Title
Mini Mental State Examination
Time Frame
6 months and 12 months
Title
Frontal Behavioral Inventory
Time Frame
6 months and 12 months
Title
Frontal Assessment Battery
Time Frame
6 months and 12 months
Title
Geriatric Depression Scale Score ( From 0 to 30)
Description
Score : 0 - 5 : normal Score : 5 - 9 : light depression Score : 10 - 30 : severe depression
Time Frame
6 months and 12 months
Title
Sense of Competence Questionnaire (SCQ)
Time Frame
6 months and 12 months
Title
Quality of Life Questionnaire (QoL-AD)
Time Frame
6 months and 12 months
Title
Hierarchical scale of internality for elderly people (EHIPA) score ( From 0 to 22)
Description
The score varies from 0 to 22. A high score corresponding to an important internality
Time Frame
6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François DARTIGUES
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bordeaux University Hospital
City
Bordeaux
ZIP/Postal Code
33079
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multidisciplinary and Personalized Care of Behavioral Disorders in Frontotemporal Lobar Degeneration.
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