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

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Fondazione IRCCS San Gerardo dei Tintori

Status

Enrolling

Conditions

Behavioral and Psychiatric Symptoms of Dementia

Treatments

Other: BPSDiary

Study type

Interventional

Funder types

Other

Identifiers

NCT05977855
BPSDiary

Details and patient eligibility

About

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).

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

Diary
Experimental group
Treatment:
Other: BPSDiary
Standard Care
No Intervention group

Trial contacts and locations

9

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Central trial contact

Lucio Tremolizzo, MD, PhD

Data sourced from clinicaltrials.gov

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