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Completed

NCT Number: NCT03606798

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

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

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Key information

Conditions

Frontotemporal Lobar Degeneration Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Metabolic Diseases Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bordeaux University Hospital

Bordeaux, 33079, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3 Home visits made by a psychologist

Other

Patient and caregiver interviews with a psychologist at home

Primary outcomes

  1. Neuropsychiatric Inventory (NPI)

    Time frame: 6 months

    Assessment of neuropsychiatric symptomatology

Secondary outcomes

  1. Neuropsychiatric Inventory (NPI)

    Time frame: 12 months

    Assessment of neuropsychiatric symptomatology

  2. Mini Mental State Examination

    Time frame: 6 months and 12 months

  3. Frontal Behavioral Inventory

    Time frame: 6 months and 12 months

  4. Frontal Assessment Battery

    Time frame: 6 months and 12 months

  5. 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. Sense of Competence Questionnaire (SCQ)

    Time frame: 6 months and 12 months

  7. Quality of Life Questionnaire (QoL-AD)

    Time frame: 6 months and 12 months

  8. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: DLFT

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 31, 2018
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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