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

Study Overview
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Brief Summary
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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).

Official Title
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Use of a Diary to Assess and Monitor Behavioral and Psychological Symptoms of Dementia

Conditions
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Behavioral and Psychiatric Symptoms of Dementia

Intervention / Treatment
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* Other: BPSDiary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diary<br> | Other: BPSDiary<br>* 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).<br>|
| No Intervention: Standard Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Zarit Burden Interview | Zarit Burden Interview difference between intervention arm and controls | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychiatric Inventory | Neuropsychiatric Inventory difference between intervention arm and controls | 3 months | 
| Olanzapine equivalents | Calculated with the Defined Daily Doses method; difference between intervention arm and controls | 3 months | 
| Satisfaction questionnaire | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral and Psychiatric Symptoms of Dementia, Randomized Clinical Trial, Diary