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

Not Applicable

Recruiting

• Conditions: Behavioral and Psychiatric Symptoms of Dementia
• Interventions: Other: BPSDiary

• Registration Number: NCT05977855
• Lead Sponsor: Fondazione IRCCS San Gerardo dei Tintori

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-10-02
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diary	BPSDiary	-

Primary Outcome Measures

Name	Time	Method
Zarit Burden Interview	3 months	Zarit Burden Interview difference between intervention arm and controls

Secondary Outcome Measures

Name	Time	Method
Olanzapine equivalents	3 months	Calculated with the Defined Daily Doses method; difference between intervention arm and controls
Neuropsychiatric Inventory	3 months	Neuropsychiatric Inventory difference between intervention arm and controls
Neuropsychiatric Inventory - Caregiver Distress Scale	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
Satisfaction questionnaire	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

Trial Locations

Locations (9)

AO Padova; 🇮🇹 Padova, Veneto, Italy

Università Sapienza; 🇮🇹 Roma, Lazio, Italy

Ospedale Multimedica; 🇮🇹 Castellanza, Lombardia, Italy

Fondazione IRCCS Don Gnocchi; 🇮🇹 Milano, Lombardia, Italy

Fondazione IRCCS San Gerardo dei Tintori [Recruiting]; 🇮🇹 Monza, Lombardia, Italy

Fondazione IRCCS Mondino; 🇮🇹 Pavia, Lombardia, Italy

Pia Fondazione Card. Panico; 🇮🇹 Tricase, Puglia, Italy

AOU Careggi; 🇮🇹 Firenze, Toscana, Italy

Ospedale SS Annunziata; 🇮🇹 Chieti, Abruzzo, Italy