NCT05977855
Recruiting
Not Applicable
Use of a Diary to Assess and Monitor Behavioral and Psychological Symptoms of Dementia
Fondazione IRCCS San Gerardo dei Tintori9 sites in 1 country300 target enrollmentJuly 1, 2023
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Behavioral and Psychiatric Symptoms of Dementia
- Sponsor
- Fondazione IRCCS San Gerardo dei Tintori
- Enrollment
- 300
- Locations
- 9
- Primary Endpoint
- Zarit Burden Interview
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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).
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Zarit Burden Interview
Time Frame: 3 months
Zarit Burden Interview difference between intervention arm and controls
Secondary Outcomes
- Olanzapine equivalents(3 months)
- Neuropsychiatric Inventory(3 months)
- Neuropsychiatric Inventory - Caregiver Distress Scale(3 months)
- Satisfaction questionnaire(3 months)
Study Sites (9)
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