Using a diary to track behavioral and psychological symptoms in dementia patients
Use of a Diary to Assess and Monitor Behavioral and Psychological Symptoms of Dementia
This study is testing if using a diary to track symptoms can help caregivers and doctors better manage behavioral and psychological issues in people with dementia compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS San Gerardo dei Tintori Academic / other |
| Locations | 9 sites (Chieti, Abruzzo and 8 other locations) |
| Trial ID | NCT05977855 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a diary in monitoring behavioral and psychological symptoms of dementia (BPSD) compared to standard care. Participants will be randomly assigned to either use the diary or receive standard care, with the goal of assessing caregiver burden, neuropsychiatric inventory scores, and medication prescriptions over three months. The study will also explore caregiver and physician satisfaction with the diary approach. By documenting symptoms, the trial seeks to identify potential triggers and improve management strategies for dementia care.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with cognitive impairment and their caregivers who are willing to participate in the study.
Not a fit: Patients who do not exhibit behavioral and psychological symptoms of dementia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce caregiver burden and improve the management of dementia symptoms.
How similar studies have performed: While the use of diaries in managing chronic conditions is not novel, this specific application in dementia care is relatively untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chieti, Abruzzo and 8 other locations
- Ospedale SS Annunziata — Chieti, Abruzzo, Italy (Not_yet_recruiting)
- Università Sapienza — Roma, Lazio, Italy (Not_yet_recruiting)
- Ospedale Multimedica — Castellanza, Lombardia, Italy (Not_yet_recruiting)
- Fondazione IRCCS Don Gnocchi — Milano, Lombardia, Italy (Not_yet_recruiting)
- Fondazione IRCCS San Gerardo dei Tintori [Recruiting] — Monza, Lombardia, Italy (Recruiting)
- Fondazione IRCCS Mondino — Pavia, Lombardia, Italy (Not_yet_recruiting)
- Pia Fondazione Card. Panico — Tricase, Puglia, Italy (Not_yet_recruiting)
- AOU Careggi — Firenze, Toscana, Italy (Not_yet_recruiting)
- AO Padova — Padova, Veneto, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Lucio Tremolizzo, MD, PhD
- Email: lucio.tremolizzo@unimib.it
- Phone: +390392333595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.