Use of a Diary to Assess and Monitor Behavioral and Psychological Symptoms of Dementia ( BPSDiary )
NCT ID: NCT05977855
Last Updated: 2023-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2023-07-01
2024-07-31
Brief Summary
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* 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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Diary
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).
Standard Care
No interventions assigned to this group
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Fondazione IRCCS San Gerardo dei Tintori
OTHER
Responsible Party
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Locations
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Ospedale SS Annunziata
Chieti, Abruzzo, Italy
Pia Fondazione Card. Panico
Tricase, Apulia, Italy
Università Sapienza
Rome, Lazio, Italy
Ospedale Multimedica
Castellanza, Lombardy, Italy
Fondazione IRCCS Don Gnocchi
Milan, Lombardy, Italy
Fondazione IRCCS San Gerardo dei Tintori [Recruiting]
Monza, Lombardy, Italy
Fondazione IRCCS Mondino
Pavia, Lombardy, Italy
AOU Careggi
Florence, Tuscany, Italy
AO Padova
Padua, Veneto, Italy
Countries
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Central Contacts
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Facility Contacts
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Laura Bonanni, MD, PhD
Role: primary
Giancarlo Logroscino, MD, PhD
Role: primary
Fabrizia D'Antonio, MD, PhD
Role: primary
Marta Zuffi, MD
Role: primary
Elisabetta Farina, MD
Role: primary
Alfredo Costa, MD, PhD
Role: primary
Valentina Bessi, MD, PhD
Role: primary
Annachiara Cagnin, MD, PhD
Role: primary
References
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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.
Other Identifiers
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BPSDiary
Identifier Type: -
Identifier Source: org_study_id
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