Behavioral and Psychiatric Symptoms of DementiaBPSDiaryNCT05977855
Use of a Diary to Assess and Monitor Behavioral and Psychological Symptoms of Dementia ( BPSDiary )
A study testing BPSDiary in people with Behavioral and Psychiatric Symptoms of Dementia, run by Fondazione IRCCS San Gerardo dei Tintori at 9 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behavioral and Psychiatric Symptoms of Dementia
- What is being tested?
- BPSDiary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 9 sitesItaly
- Study dates
- 1 Jul 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Refusal to consent to participate in the study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Italy9 sites, 9 recruiting
- Not yet recruiting
Ospedale Multimedica
Castellanza, Lombardy, 21053
Marta Zuffi, MD
Marta Zuffi, MD
- Not yet recruiting
Ospedale SS Annunziata
Chieti, Abruzzo, 66100
Laura Bonanni, MD, PhD
Laura Bonanni, MD, PhD
- Not yet recruiting
AOU Careggi
Florence, Tuscany, 50134
Valentina Bessi, MD, PhD
Valentina Bessi, MD, PhD
- Not yet recruiting
Fondazione IRCCS Don Gnocchi
Milan, Lombardy, 20148
Elisabetta Farina, MD
Elisabetta Farina, MD
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori [Recruiting]
Monza, Lombardy, 20900
Lucio Tremolizzo, MD, PhD, +390392333595, lucio.tremolizzo@unimib.it
Federico Emanuele Pozzi, MD, +393494113421, federicoemanuele.pozzi@gmail.com
- Not yet recruiting
AO Padova
Padova, Veneto, MD, PhD
Annachiara Cagnin, MD, PhD
Annachiara Cagnin, MD, PhD
- Not yet recruiting
Fondazione IRCCS Mondino
Pavia, Lombardy, 27100
Alfredo Costa, MD, PhD
Alfredo Costa, MD, PhD
- Not yet recruiting
Università Sapienza
Rome, Lazio, 00185
Fabrizia D'Antonio, MD, PhD
Fabrizia D'Antonio, MD, PhD
- Not yet recruiting
Pia Fondazione Card. Panico
Tricase, Apulia, 73039
Giancarlo Logroscino, MD, PhD
Giancarlo Logroscino, MD, PhD
About this study
Official title: Use of a Diary to Assess and Monitor Behavioral and Psychological Symptoms of Dementia
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).
- Being tested
- BPSDiary
- Keywords
- Behavioral and Psychiatric Symptoms of Dementia, Randomized Clinical Trial, Diary
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPSDiaryOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Diary | Experimental | Not described Receives: Other: BPSDiary |
| Standard Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zarit Burden Interview
Zarit Burden Interview difference between intervention arm and controls
Measured: 3 months
Secondary outcomes (4)
Neuropsychiatric Inventory
Neuropsychiatric Inventory difference between intervention arm and controls
Measured: 3 months
Olanzapine equivalents
Calculated with the Defined Daily Doses method; difference between intervention arm and controls
Measured: 3 months
Satisfaction questionnaire
A questionnaire to evaluate care-related satisfaction in caregivers and physicians (range 0-32, higher scores indicate better outcomes); difference between intervention arm and controls
Measured: 3 months
Neuropsychiatric Inventory - Caregiver Distress Scale
Subscale of NPI-caregiver distress scale relative to the domains included in the diary (range 0-35, higher scores indicate worse outcomes); difference between intervention arm and controls
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Jul 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavioral and Psychiatric Symptoms of DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS San Gerardo dei Tintori
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977855
- Sponsor's protocol ID
- BPSDiary
- Acronym
- BPSDiary
- Status last verified
- Sep 2023
- First submitted
- 28 Jul 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pozzi FE, Cali L, D'Antonio F, Altomare AI, Sepe Monti M, Panigutti M, Di Crosta A, Palumbo R, Bonanni L, Carlucci V, Busse C, Cagning A, Urso D, Vilella D, Logroscino G, Alberoni M, Bellinvia A, Farina E, de Rino F, Gavazzi A, Zuffi M, Bruno G, Bessi V, Cotta Ramusino M, Perini G, Costa A, Ferrarese C, Appollonio I, Tremolizzo L. BPSDiary study protocol: a multi-center randomized controlled trial to compare the efficacy of a BPSD diary vs. standard care in reducing caregiver's burden. Front Dement. 2023 Dec 18;2:1301280. doi: 10.3389/frdem.2023.1301280. eCollection 2023.
PubMed 39081982
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Diary to Assess and Monitor Behavioral and Psychological Symptoms of Dementia
- ClinicalTrials.gov ID
- NCT05977855
- Acronym / sponsor ID
- BPSDiary / BPSDiary
- Keywords
- Behavioral and Psychiatric Symptoms of Dementia, Randomized Clinical Trial, Diary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione IRCCS San Gerardo dei TintoriUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diary | Experimental | Other: BPSDiary |
| Standard Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal to consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPSDiaryThe 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). | Other | Diary |
Primary outcome
Zarit Burden Interview
Time frame: 3 months
Zarit Burden Interview difference between intervention arm and controls
4 secondary outcomes
Neuropsychiatric Inventory
Time frame: 3 months
Olanzapine equivalents
Time frame: 3 months
Satisfaction questionnaire
Time frame: 3 months
Neuropsychiatric Inventory - Caregiver Distress Scale
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Derived from this study: PubMed 39081982Pozzi FE, Cali L, D'Antonio F, Altomare AI, Sepe Monti M, Panigutti M, Di Crosta A, Palumbo R, Bonanni L, Carlucci V, Busse C, Cagning A, Urso D, Vilella D, Logroscino G, Alberoni M, Bellinvia A, Farina E, de Rino F, Gavazzi A, Zuffi M, Bruno G, Bessi V, Cotta Ramusino M, Perini G, Costa A, Ferrarese C, Appollonio I, Tremolizzo L. BPSDiary study protocol: a multi-center randomized controlled trial to compare the efficacy of a BPSD diary vs. standard care in reducing caregiver's burden. Front Dement. 2023 Dec 18;2:1301280. doi: 10.3389/frdem.2023.1301280. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BPSDiary in people with Behavioral and Psychiatric Symptoms of Dementia, run by Fondazione IRCCS San Gerardo dei Tintori at 9 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucio Tremolizzo, MD, PhD (+390392333595, lucio.tremolizzo@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zarit Burden Interview (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05977855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.