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

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ClinicalTrials.gov Identifier: NCT05977855
Recruitment Status : Recruiting
First Posted : August 7, 2023
Last Update Posted : October 2, 2023
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS San Gerardo dei Tintori

Study Description
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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).

Condition or disease Intervention/treatment Phase
Behavioral and Psychiatric Symptoms of Dementia Other: BPSDiary Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of a Diary to Assess and Monitor Behavioral and Psychological Symptoms of Dementia
Actual Study Start Date : July 1, 2023
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arms and Interventions
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Arm Intervention/treatment
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).
No Intervention: Standard Care


Outcome Measures
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Primary Outcome Measures :
  1. Zarit Burden Interview [ Time Frame: 3 months ]
    Zarit Burden Interview difference between intervention arm and controls


Secondary Outcome Measures :
  1. Neuropsychiatric Inventory [ Time Frame: 3 months ]
    Neuropsychiatric Inventory difference between intervention arm and controls

  2. Olanzapine equivalents [ Time Frame: 3 months ]
    Calculated with the Defined Daily Doses method; difference between intervention arm and controls

  3. 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

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05977855


Contacts
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Contact: Lucio Tremolizzo, MD, PhD +390392333595 lucio.tremolizzo@unimib.it

Locations
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Italy
Ospedale SS Annunziata Not yet recruiting
Chieti, Abruzzo, Italy, 66100
Contact: Laura Bonanni, MD, PhD         
Principal Investigator: Laura Bonanni, MD, PhD         
Università Sapienza Not yet recruiting
Roma, Lazio, Italy, 00185
Contact: Fabrizia D'Antonio, MD, PhD         
Principal Investigator: Fabrizia D'Antonio, MD, PhD         
Ospedale Multimedica Not yet recruiting
Castellanza, Lombardia, Italy, 21053
Contact: Marta Zuffi, MD         
Principal Investigator: Marta Zuffi, MD         
Fondazione IRCCS Don Gnocchi Not yet recruiting
Milano, Lombardia, Italy, 20148
Contact: Elisabetta Farina, MD         
Principal Investigator: Elisabetta Farina, MD         
Fondazione IRCCS San Gerardo dei Tintori [Recruiting] Recruiting
Monza, Lombardia, Italy, 20900
Contact: Lucio Tremolizzo, MD, PhD    +390392333595    lucio.tremolizzo@unimib.it   
Contact: Federico Emanuele Pozzi, MD    +393494113421    federicoemanuele.pozzi@gmail.com   
Principal Investigator: Lucio Tremolizzo, MD, PhD         
Sub-Investigator: Federico Emanuele Pozzi, MD         
Sub-Investigator: Luisa Calì, MD         
Fondazione IRCCS Mondino Not yet recruiting
Pavia, Lombardia, Italy, 27100
Contact: Alfredo Costa, MD, PhD         
Principal Investigator: Alfredo Costa, MD, PhD         
Pia Fondazione Card. Panico Not yet recruiting
Tricase, Puglia, Italy, 73039
Contact: Giancarlo Logroscino, MD, PhD         
Principal Investigator: Giancarlo Logroscino, MD, PhD         
AOU Careggi Not yet recruiting
Firenze, Toscana, Italy, 50134
Contact: Valentina Bessi, MD, PhD         
Principal Investigator: Valentina Bessi, MD, PhD         
Sub-Investigator: Arianna Ida Altomare, MD         
AO Padova Not yet recruiting
Padova, Veneto, Italy, MD, PhD
Contact: Annachiara Cagnin, MD, PhD         
Principal Investigator: Annachiara Cagnin, MD, PhD         
Sponsors and Collaborators
Fondazione IRCCS San Gerardo dei Tintori
More Information
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Responsible Party: Fondazione IRCCS San Gerardo dei Tintori
ClinicalTrials.gov Identifier: NCT05977855    
Other Study ID Numbers: BPSDiary
First Posted: August 7, 2023    Key Record Dates
Last Update Posted: October 2, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione IRCCS San Gerardo dei Tintori:
Behavioral and Psychiatric Symptoms of Dementia
Randomized Clinical Trial
Diary
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders