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

March 30, 2022 updated by: University Hospital, Bordeaux
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33079
        • Bordeaux University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multidisciplinary and personalized care
Personalized care and proposals bring by a team of experts : neurologists ; geriatrician ; psychologist.
Other: 3 Home visits made by a psychologist
Patient and caregiver interviews with a psychologist at home
No Intervention: Reference care
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)
Time Frame: 6 months
Assessment of neuropsychiatric symptomatology
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Jean-François DARTIGUES, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2018

Primary Completion (Actual)

October 6, 2021

Study Completion (Actual)

October 6, 2021

Study Registration Dates

First Submitted

July 20, 2018

First Submitted That Met QC Criteria

July 20, 2018

First Posted (Actual)

July 31, 2018

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX2015/06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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