Use of a Diary to Assess and Monitor Behavioral and Psychological Symptoms of Dementia ( BPSDiary )

Behavioral and Psychiatric Symptoms of Dementia Clinical Trial

— BPSDiary  

Official title:

Use of a Diary to Assess and Monitor Behavioral and Psychological Symptoms of Dementia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05977855
• Other study ID #: BPSDiary
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: September 2023
• Source: Fondazione IRCCS San Gerardo dei Tintori
• Contact: Lucio Tremolizzo, MD, PhD
• Phone: +390392333595
• Email: lucio.tremolizzo[@]unimib.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavioral and Psychiatric Symptoms of Dementia
• Dementia

Intervention

Other:
• BPSDiary
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).

Locations

Country	Name	City	State
Italy	Ospedale Multimedica	Castellanza	Lombardia
Italy	Ospedale SS Annunziata	Chieti	Abruzzo
Italy	AOU Careggi	Firenze	Toscana
Italy	Fondazione IRCCS Don Gnocchi	Milano	Lombardia
Italy	Fondazione IRCCS San Gerardo dei Tintori [Recruiting]	Monza	Lombardia
Italy	AO Padova	Padova	Veneto
Italy	Fondazione IRCCS Mondino	Pavia	Lombardia
Italy	Università Sapienza	Roma	Lazio
Italy	Pia Fondazione Card. Panico	Tricase	Puglia

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS San Gerardo dei Tintori

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Zarit Burden Interview	Zarit Burden Interview difference between intervention arm and controls	3 months
Secondary	Neuropsychiatric Inventory	Neuropsychiatric Inventory difference between intervention arm and controls	3 months
Secondary	Olanzapine equivalents	Calculated with the Defined Daily Doses method; difference between intervention arm and controls	3 months
Secondary	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	3 months
Secondary	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	3 months