Published in:
Open Access 01-12-2014 | Study protocol
Initial and long-term evaluation of patients with Alzheimer’s after hospitalization in cognitive and behavioural units: the EVITAL study design
Published in: BMC Psychiatry | Issue 1/2014
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Background
Alzheimer’s disease and related disorders are characterized by cognitive impairment associated with behavioral and psychological symptoms of dementia. These symptoms have significant consequences for both the patient and his family environment. While risk factors for behavioral disorders have been identified in several studies, few studies have focused on the evolution of these disorders. Moreover, it is important to identify factors linked to the long-term evolution of behavioral disorders, as well as patients’ and caregivers’ quality of life. Our purpose is to present the methodology of the EVITAL study, which primary objective is to determine the factors associated with the evolution of behavioral disorders among patients with Alzheimer’s disease and related disorders during the year following their hospitalization in cognitive and behavioral units. Secondary objectives were 1) to assess the factors related to the evolution of behavioral disorders during hospitalization in cognitive and behavioral units; 2) to identify the factors linked to patients’ and caregivers’ quality of life, as well as caregivers’ burden; 3) to assess the factors associated with rehospitalization of the patients for behavioral disorders in the year following their hospitalization in cognitive and behavioral units.
Method/Design
A multicenter, prospective cohort of patients with Alzheimer’s disease and related disorders as well as behavioral disorders who are hospitalized in cognitive and behavioral units.
The patients will be included in the study for a period of 24 months and followed-up for 12 months. Socio-demographic and environmental data, behavioral disorders, medications, patients’ and caregivers’ quality of life as well as caregivers’ burden will be assessed throughout hospitalization in cognitive and behavioral units. Follow-up will be performed at months 3, 6 and 12 after hospitalization. Socio-demographic and environmental data, behavioral disorders, medications, patients’ and caregivers’ quality of life, unplanned rehospitalization as well as caregivers’ burden will also be assessed at each follow-up interview.
Discussion
The present study should help better identify the factors associated with reduction or stabilization of the behavioral and psychological symptoms of dementia in patients with Alzheimer’s disease. It could therefore help clinicians to better manage these symptoms.
Trial registration
Clinical Trials NCT01901263. Registered July 9, 2013.