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

Primary Purpose

Behavioral and Psychiatric Symptoms of Dementia

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

BPSDiary

About this trial

This is an interventional treatment trial for Behavioral and Psychiatric Symptoms of Dementia focused on measuring Behavioral and Psychiatric Symptoms of Dementia, Randomized Clinical Trial, Diary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ospedale SS Annunziata
Università Sapienza
Ospedale Multimedica
Fondazione IRCCS Don Gnocchi
Fondazione IRCCS San Gerardo dei Tintori [Recruiting]Recruiting
Fondazione IRCCS Mondino
Pia Fondazione Card. Panico
AOU Careggi
AO Padova

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diary

Standard Care

Arm Description

Outcomes

Primary Outcome Measures

Zarit Burden Interview

Zarit Burden Interview difference between intervention arm and controls

Secondary Outcome Measures

Neuropsychiatric Inventory

Neuropsychiatric Inventory difference between intervention arm and controls

Olanzapine equivalents

Calculated with the Defined Daily Doses method; difference between intervention arm and controls

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

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

Full Information

NCT ID

NCT05977855

First Posted

July 28, 2023

Last Updated

September 28, 2023

Sponsor

Fondazione IRCCS San Gerardo dei Tintori

1. Study Identification

Unique Protocol Identification Number

NCT05977855

Brief Title

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

Acronym

BPSDiary

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2023 (Actual)

Primary Completion Date

July 31, 2024 (Anticipated)

Study Completion Date

July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondazione IRCCS San Gerardo dei Tintori

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Behavioral and Psychiatric Symptoms of Dementia

Keywords

Behavioral and Psychiatric Symptoms of Dementia, Randomized Clinical Trial, Diary

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diary

Arm Type

Experimental

Arm Title

Standard Care

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

BPSDiary

Intervention Description

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).

Primary Outcome Measure Information:

Title

Zarit Burden Interview

Description

Zarit Burden Interview difference between intervention arm and controls

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Neuropsychiatric Inventory

Description

Neuropsychiatric Inventory difference between intervention arm and controls

Time Frame

3 months

Title

Olanzapine equivalents

Description

Calculated with the Defined Daily Doses method; difference between intervention arm and controls

Time Frame

3 months

Title

Satisfaction questionnaire

Description

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

Title

Neuropsychiatric Inventory - Caregiver Distress Scale

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lucio Tremolizzo, MD, PhD

Phone

+390392333595

lucio.tremolizzo@unimib.it

Facility Information:

Facility Name

Ospedale SS Annunziata

City

Chieti

State/Province

Abruzzo

ZIP/Postal Code

66100

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laura Bonanni, MD, PhD

First Name & Middle Initial & Last Name & Degree

Laura Bonanni, MD, PhD

Facility Name

Università Sapienza

City

Roma

State/Province

Lazio

ZIP/Postal Code

00185

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fabrizia D'Antonio, MD, PhD

First Name & Middle Initial & Last Name & Degree

Fabrizia D'Antonio, MD, PhD

Facility Name

Ospedale Multimedica

City

Castellanza

State/Province

Lombardia

ZIP/Postal Code

21053

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marta Zuffi, MD

First Name & Middle Initial & Last Name & Degree

Marta Zuffi, MD

Facility Name

Fondazione IRCCS Don Gnocchi

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20148

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elisabetta Farina, MD

First Name & Middle Initial & Last Name & Degree

Elisabetta Farina, MD

Facility Name

Fondazione IRCCS San Gerardo dei Tintori [Recruiting]

City

Monza

State/Province

Lombardia

ZIP/Postal Code

20900

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lucio Tremolizzo, MD, PhD

Phone

+390392333595

lucio.tremolizzo@unimib.it

First Name & Middle Initial & Last Name & Degree

Federico Emanuele Pozzi, MD

Phone

+393494113421

federicoemanuele.pozzi@gmail.com

First Name & Middle Initial & Last Name & Degree

Lucio Tremolizzo, MD, PhD

First Name & Middle Initial & Last Name & Degree

Federico Emanuele Pozzi, MD

First Name & Middle Initial & Last Name & Degree

Luisa Calì, MD

Facility Name

Fondazione IRCCS Mondino

City

Pavia

State/Province

Lombardia

ZIP/Postal Code

27100

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alfredo Costa, MD, PhD

First Name & Middle Initial & Last Name & Degree

Alfredo Costa, MD, PhD

Facility Name

Pia Fondazione Card. Panico

City

Tricase

State/Province

Puglia

ZIP/Postal Code

73039

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Giancarlo Logroscino, MD, PhD

First Name & Middle Initial & Last Name & Degree

Giancarlo Logroscino, MD, PhD

Facility Name

AOU Careggi

City

Firenze

State/Province

Toscana

ZIP/Postal Code

50134

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Valentina Bessi, MD, PhD

First Name & Middle Initial & Last Name & Degree

Valentina Bessi, MD, PhD

First Name & Middle Initial & Last Name & Degree

Arianna Ida Altomare, MD

Facility Name

AO Padova

City

Padova

State/Province

Veneto

ZIP/Postal Code

MD, PhD

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Annachiara Cagnin, MD, PhD

First Name & Middle Initial & Last Name & Degree

Annachiara Cagnin, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

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

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