The goal of this randomized clinical trial is to compare the efficacy of the use of a diary to record behavioral and psychological symptoms of dementia (BPSD) in persons with dementia. The main questions it aims to answer are: * Does the use of a diary lead to a reduction of the caregiver's burden at 3 months, compared with standard care? * Does the use of a diary lead to a reduction of the neuropsychiatric inventory (NPI) score at 3 months, compared with standard care? * Does the use of a diary result in less psychotropic drugs prescribed to the patient at 3 months compared with standard care? * Are physicians and caregivers satisfied with managing patients with the use of a diary? * Does the use of a diary reduce the caregiver's stress related to BPSD at 3 months, compared with standard care? Participants will be randomly assigned to either the use of a diary or a control group. Caregivers in the diary arm will be asked to fill in a diary with BPSD including triggers, severity, day and hour, to be analyzed by physicians to prescribe appropriate pharmacological or non-pharmacological interventions. The control group will receive usual care (i.e., appropriate interventions will be applied after interviewing the caregiver and/or visiting the patient).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
The BPSDiary is a diary to register severity, hour, day and triggers of a number of BPSD (namely, agitation, aggression, delusions/hallucinations, insomnia, aberrant motor behavior).
Ospedale SS Annunziata
Chieti, Abruzzo, Italy
NOT_YET_RECRUITINGPia Fondazione Card. Panico
Tricase, Apulia, Italy
NOT_YET_RECRUITINGUniversità Sapienza
Rome, Lazio, Italy
NOT_YET_RECRUITINGOspedale Multimedica
Castellanza, Lombardy, Italy
NOT_YET_RECRUITINGFondazione IRCCS Don Gnocchi
Milan, Lombardy, Italy
NOT_YET_RECRUITINGFondazione IRCCS San Gerardo dei Tintori [Recruiting]
Monza, Lombardy, Italy
RECRUITINGFondazione IRCCS Mondino
Pavia, Lombardy, Italy
NOT_YET_RECRUITINGAOU Careggi
Florence, Tuscany, Italy
NOT_YET_RECRUITINGAO Padova
Padua, Veneto, Italy
NOT_YET_RECRUITINGZarit Burden Interview
Zarit Burden Interview difference between intervention arm and controls
Time frame: 3 months
Neuropsychiatric Inventory
Neuropsychiatric Inventory difference between intervention arm and controls
Time frame: 3 months
Olanzapine equivalents
Calculated with the Defined Daily Doses method; difference between intervention arm and controls
Time frame: 3 months
Satisfaction questionnaire
A questionnaire to evaluate care-related satisfaction in caregivers and physicians (range 0-32, higher scores indicate better outcomes); difference between intervention arm and controls
Time frame: 3 months
Neuropsychiatric Inventory - Caregiver Distress Scale
Subscale of NPI-caregiver distress scale relative to the domains included in the diary (range 0-35, higher scores indicate worse outcomes); difference between intervention arm and controls
Time frame: 3 months
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