UnknownNot Applicable

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

Italy300 participantsStarted 2023-07-01

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Zarit Burden Interview

Timeframe: 3 months

Trial details

NCT IDNCT05977855

SponsorFondazione IRCCS San Gerardo dei Tintori

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-31

Contact for this trial

Lucio Tremolizzo, MD, PhD

+390392333595 lucio.tremolizzo@unimib.it

View on ClinicalTrials.gov More Behavioral and Psychiatric Symptoms of Dementia trials