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Search / Trial NCT05977855

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

Launched by FONDAZIONE IRCCS SAN GERARDO DEI TINTORI · Jul 28, 2023

Trial Information

Current as of August 23, 2025

Recruiting

Keywords

Behavioral And Psychiatric Symptoms Of Dementia Randomized Clinical Trial Diary

ClinConnect Summary

This clinical trial, called BPSDiary, is studying the use of a diary to help track and manage behavioral and psychological symptoms in people with dementia. By keeping a diary, caregivers can record specific behaviors, triggers, and their severity throughout the day. The goal is to see if this method can reduce the stress and burden on caregivers, lower the use of certain medications, and improve overall satisfaction for both caregivers and healthcare providers when managing these symptoms.

To participate, individuals need to have a diagnosis of cognitive impairment and must have a caregiver who is willing to help with the study. The caregiver should live with the participant or be able to provide 24-hour coverage. Participants will be randomly divided into two groups: one will use the diary, while the other will receive standard care. Caregivers in the diary group will fill out the diary for three months, which will help doctors understand the patient’s needs better and provide more tailored treatments. This study is currently looking for volunteers and aims to improve how dementia symptoms are managed at home.

Gender

ALL

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

About Fondazione Irccs San Gerardo Dei Tintori

Fondazione IRCCS San Gerardo dei Tintori is a leading research institution in Italy dedicated to advancing healthcare through innovative clinical trials and translational research. Affiliated with the Italian National Health Service, the foundation focuses on a wide range of medical disciplines, emphasizing patient-centered approaches and multidisciplinary collaboration. With a commitment to improving clinical outcomes, the foundation actively engages in the development and implementation of cutting-edge therapies and medical technologies, striving to enhance the quality of life for patients while contributing to the global medical community.

Locations

Firenze, Toscana, Italy

Chieti, Abruzzo, Italy

Roma, Lazio, Italy

Castellanza, Lombardia, Italy

Milano, Lombardia, Italy

Monza, Lombardia, Italy

Pavia, Lombardia, Italy

Tricase, Puglia, Italy

Padova, Veneto, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported