NCT05977855

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

July 28, 2023

Last Update Submit

September 28, 2023

Conditions

Behavioral and Psychiatric Symptoms of Dementia

Keywords

Behavioral and Psychiatric Symptoms of DementiaRandomized Clinical TrialDiary

Outcome Measures

Primary Outcomes (1)

  • Zarit Burden Interview

    Zarit Burden Interview difference between intervention arm and controls

    3 months

Secondary Outcomes (4)

  • Neuropsychiatric Inventory

    3 months

  • Olanzapine equivalents

    3 months

  • Satisfaction questionnaire

    3 months

  • Neuropsychiatric Inventory - Caregiver Distress Scale

    3 months

Study Arms (2)

Diary

EXPERIMENTAL
Other: BPSDiary

Standard Care

NO INTERVENTION

Interventions

BPSDiaryOTHER

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).

Diary

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Refusal to consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Ospedale SS Annunziata

Chieti, Abruzzo, 66100, Italy

NOT YET RECRUITING

Pia Fondazione Card. Panico

Tricase, Apulia, 73039, Italy

NOT YET RECRUITING

Università Sapienza

Rome, Lazio, 00185, Italy

NOT YET RECRUITING

Ospedale Multimedica

Castellanza, Lombardy, 21053, Italy

NOT YET RECRUITING

Fondazione IRCCS Don Gnocchi

Milan, Lombardy, 20148, Italy

NOT YET RECRUITING

Fondazione IRCCS San Gerardo dei Tintori [Recruiting]

Monza, Lombardy, 20900, Italy

RECRUITING

Fondazione IRCCS Mondino

Pavia, Lombardy, 27100, Italy

NOT YET RECRUITING

AOU Careggi

Florence, Tuscany, 50134, Italy

NOT YET RECRUITING

AO Padova

Padua, Veneto, MD, PhD, Italy

NOT YET RECRUITING

Related Publications (1)

  • Pozzi FE, Cali L, D'Antonio F, Altomare AI, Sepe Monti M, Panigutti M, Di Crosta A, Palumbo R, Bonanni L, Carlucci V, Busse C, Cagning A, Urso D, Vilella D, Logroscino G, Alberoni M, Bellinvia A, Farina E, de Rino F, Gavazzi A, Zuffi M, Bruno G, Bessi V, Cotta Ramusino M, Perini G, Costa A, Ferrarese C, Appollonio I, Tremolizzo L. BPSDiary study protocol: a multi-center randomized controlled trial to compare the efficacy of a BPSD diary vs. standard care in reducing caregiver's burden. Front Dement. 2023 Dec 18;2:1301280. doi: 10.3389/frdem.2023.1301280. eCollection 2023.

    PMID: 39081982DERIVED

MeSH Terms

Conditions

Behavior

Central Study Contacts

Lucio Tremolizzo, MD, PhD

CONTACT

+390392333595lucio.tremolizzo@unimib.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2023

First Posted

August 7, 2023

Study Start

July 1, 2023

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

October 2, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(9)