NCT05977855

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Fondazione IRCCS San Gerardo dei Tintori · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Behavioral and Psychiatric Symptoms of Dementia

Interventions

Type	Name	Description
OTHER	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).

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2023-08-07
• Last updated: 2023-10-02

Locations

9 sites across 1 country: Italy