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

NCT ID: NCT03606798

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-21
• Study Completion Date: 2021-10-06

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

Conditions

Frontotemporal Lobar Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Multidisciplinary and personalized care

Personalized care and proposals bring by a team of experts : neurologists ; geriatrician ; psychologist.

Group Type: EXPERIMENTAL

3 Home visits made by a psychologist

Intervention Type: OTHER

Patient and caregiver interviews with a psychologist at home

Reference care

Standard clinical evaluations of patient with Frontotemporal Lobar Degeneration.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

3 Home visits made by a psychologist

Patient and caregiver interviews with a psychologist at home

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-François DARTIGUES

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

Bordeaux University Hospital

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX2015/06

Identifier Type: -

Identifier Source: org_study_id