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

September 28, 2023 updated by: Fondazione IRCCS San Gerardo dei Tintori

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Zarit Burden Interview
Time Frame: 3 months
Zarit Burden Interview difference between intervention arm and controls
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neuropsychiatric Inventory
Time Frame: 3 months
Neuropsychiatric Inventory difference between intervention arm and controls
3 months
Olanzapine equivalents
Time Frame: 3 months
Calculated with the Defined Daily Doses method; difference between intervention arm and controls
3 months
Satisfaction questionnaire
Time Frame: 3 months
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
Time Frame: 3 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione IRCCS San Gerardo dei Tintori

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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