Predictive Factors of Autonomy Loss in Real-life Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: no intervention.
- Who it may be relevant to
- Registry conditions: Memory Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Predictive Factors Associated With Impairment in Functional Autonomy in a Regional Real-life Cohort of Patients With Alzheimer's Disease or Related Disorders (ADRD)
Overview
The Alzheimer's disease or related disorders (ADRD) are among the most disabling diseases because of their main features such as cognitive impairment, loss of functional autonomy and behavioural disorders. In absence of current curative treatment, the identification of the predictive risk factors of progression of the disease, evaluated through its main symptoms, represents a major stake of public health. The Investigators aim at developing a regional database, which includes the patient medical records on a prospective basis, in collaboration with the medical and administrative staff and with the University hospital computer science departments. The main objective is to study the predictive factors associated with change in functional autonomy level, measured every 6 to 12 months in centres across Region Auvergne Rhone-Alpes in France. The real-life study population will consist in about 5400 patients with ADRD. The inclusion period will be of 3 years, the length of follow-up of each patient will be of 10 years max for a total study length of 13 years.
Interventions
- Other no intervention
This is study carried out in current practice. Patients are undergoing a medical examination in a memory center, with extensive and systematic evaluations for the study involving the following tests: IADL, DAD6, New AGGIR, NPI, and mini-Zarit) assessing the functions (autonomy, behavior and caregiver burden).
Primary outcome measures
- Functional autonomy level [Time frame: from 6 months to 12 months interval]
- Functional autonomy level [Time frame: from 6 months to 12 months interval]
- Functional autonomy level [Time frame: from 6 months to 12 months interval]
Eligibility criteria
Inclusion criteria
- Patients aged 18 years and older, undergoing a medical visit in a memory center or neuro-cognition service
- Patients living at home or in housing
- Patients with memory impairment, at all stage of the disease
Exclusion criteria
- Patients in institution
- Patients under legal protection
- Patients with a hearing or visual impairment, which prevents carrying out examinations
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
France · 5 centers
- Hôpital Dugoujon — Caluire-et-Cuire
- Centre Hospitalier Lyon Sud — Lyon
- Service de neuro-cognition et neuro-ophtalmologie du Groupement Hospitalier Est — Lyon
- CHU Saint-Etienne — Saint-Etienne
- Centre Mémoire de Ressources et de Recherche de Lyon — Villeurbanne
Identifiers
NCT: NCT03894254 · 69HCL18_0613