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

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

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 Overview

• Status: Recruiting
• Conditions: Behavioral and Psychiatric Symptoms of Dementia
• Intervention / Treatment: Other: BPSDiary

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucio Tremolizzo, MD, PhD; Phone Number: +390392333595; Email: lucio.tremolizzo@unimib.it

Study Locations

• Italy
  • Abruzzo
    • Chieti, Abruzzo, Italy, 66100
      • Not yet recruiting
      • Ospedale SS Annunziata
      • Contact: Laura Bonanni, MD, PhD
      • Principal Investigator: Laura Bonanni, MD, PhD
  • Lazio
    • Roma, Lazio, Italy, 00185
      • Not yet recruiting
      • Università Sapienza
      • Contact: Fabrizia D'Antonio, MD, PhD
      • Principal Investigator: Fabrizia D'Antonio, MD, PhD
  • Lombardia
    • Castellanza, Lombardia, Italy, 21053
      • Not yet recruiting
      • Ospedale MultiMedica
      • Contact: Marta Zuffi, MD
      • Principal Investigator: Marta Zuffi, MD
    • Milano, Lombardia, Italy, 20148
      • Not yet recruiting
      • Fondazione IRCCS Don Gnocchi
      • Contact: Elisabetta Farina, MD
      • Principal Investigator: Elisabetta Farina, MD
    • Monza, Lombardia, Italy, 20900
      • Recruiting
      • Fondazione IRCCS San Gerardo dei Tintori [Recruiting]
      • Sub-Investigator: Federico Emanuele Pozzi, MD
      • Contact: Lucio Tremolizzo, MD, PhD; Phone Number: +390392333595; Email: lucio.tremolizzo@unimib.it
      • Contact: Federico Emanuele Pozzi, MD; Phone Number: +393494113421; Email: federicoemanuele.pozzi@gmail.com
      • Principal Investigator: Lucio Tremolizzo, MD, PhD
      • Sub-Investigator: Luisa Calì, MD
    • Pavia, Lombardia, Italy, 27100
      • Not yet recruiting
      • Fondazione IRCCS Mondino
      • Contact: Alfredo Costa, MD, PhD
      • Principal Investigator: Alfredo Costa, MD, PhD
  • Puglia
    • Tricase, Puglia, Italy, 73039
      • Not yet recruiting
      • Pia Fondazione Card. Panico
      • Contact: Giancarlo Logroscino, MD, PhD
      • Principal Investigator: Giancarlo Logroscino, MD, PhD
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • Not yet recruiting
      • AOU Careggi
      • Principal Investigator: Valentina Bessi, MD, PhD
      • Contact: Valentina Bessi, MD, PhD
      • Sub-Investigator: Arianna Ida Altomare, MD
  • Veneto
    • Padova, Veneto, Italy, MD, PhD
      • Not yet recruiting
      • Ao Padova
      • Contact: Annachiara Cagnin, MD, PhD
      • Principal Investigator: Annachiara Cagnin, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care
Experimental: Diary	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Zarit Burden Interview	Zarit Burden Interview difference between intervention arm and controls	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropsychiatric Inventory	Neuropsychiatric Inventory difference between intervention arm and controls	3 months
Olanzapine equivalents	Calculated with the Defined Daily Doses method; difference between intervention arm and controls	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	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	3 months

Collaborators and Investigators

• Sponsor: Fondazione IRCCS San Gerardo dei Tintori

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Randomized Clinical Trial; Diary; Behavioral and Psychiatric Symptoms of Dementia
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: BPSDiary

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No