Clinical trial NCT05977855: Use of a Diary to Assess and Monitor Behavioral and Psychological Symptoms of Dementia ( BPSDiary )
Official title: Use of a Diary to Assess and Monitor Behavioral and Psychological Symptoms of Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Behavioral and Psychiatric Symptoms of Dementia
Keywords: Behavioral and Psychiatric Symptoms of Dementia
Randomized Clinical Trial
Diary
Lead sponsor: Fondazione IRCCS San Gerardo dei Tintori
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cognitive impairment (neurodegenerative or vascular)
* Caregiver and patient willing to participate in the study
* Caregiver living with the patient or able to cover all 24 hours
* Presence of BPSD pertaining to the hyperactivity-irritability-impulsivity-disinhibition cluster (HIDA)
* Signed informed consent before the beginning of the study

Exclusion Criteria:

* Refusal to consent to participate in the study

Primary outcomes:
measure: Zarit Burden Interview
timeFrame: 3 months
Secondary outcomes:
measure: Neuropsychiatric Inventory
timeFrame: 3 months
measure: Olanzapine equivalents
timeFrame: 3 months
measure: Satisfaction questionnaire
timeFrame: 3 months
measure: Neuropsychiatric Inventory - Caregiver Distress Scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Ospedale SS Annunziata
state: Abruzzo
city: Roma
country: Italy
facility: Università Sapienza
state: Lazio
city: Castellanza
country: Italy
facility: Ospedale Multimedica
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Don Gnocchi
state: Lombardia
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori [Recruiting]
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione IRCCS Mondino
state: Lombardia
city: Tricase
country: Italy
facility: Pia Fondazione Card. Panico
state: Puglia
city: Firenze
country: Italy
facility: AOU Careggi
state: Toscana
city: Padova
country: Italy
facility: AO Padova
state: Veneto
Study officials:
References: