Behavioral and Psychiatric Symptoms of Dementia
Conditions
Keywords
Behavioral and Psychiatric Symptoms of Dementia, Randomized Clinical Trial, Diary
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).
Interventions
OTHERBPSDiary
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).
Sponsors
Fondazione IRCCS San Gerardo dei Tintori
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Zarit Burden Interview | 3 months | Zarit Burden Interview difference between intervention arm and controls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychiatric Inventory | 3 months | Neuropsychiatric Inventory difference between intervention arm and controls |
| Olanzapine equivalents | 3 months | Calculated with the Defined Daily Doses method; 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 |
| 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 |
Countries
Italy
Contacts
Primary ContactLucio Tremolizzo, MD, PhD
Outcome results
None listed