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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diary | Experimental |
| |
| Standard Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPSDiary | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Zarit Burden Interview | Zarit Burden Interview difference between intervention arm and controls | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychiatric Inventory | Neuropsychiatric Inventory difference between intervention arm and controls | 3 months |
| Olanzapine equivalents | Calculated with the Defined Daily Doses method; difference between intervention arm and controls |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucio Tremolizzo, MD, PhD | Contact | +390392333595 | lucio.tremolizzo@unimib.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale SS Annunziata | Not yet recruiting | Chieti | Abruzzo | 66100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39081982 | Derived | 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. |
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| ID | Term |
|---|---|
| D001519 | Behavior |
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| 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 | 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 | 3 months |
| Pia Fondazione Card. Panico | Not yet recruiting | Tricase | Apulia | 73039 | Italy |
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| Università Sapienza | Not yet recruiting | Rome | Lazio | 00185 | Italy |
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| Ospedale Multimedica | Not yet recruiting | Castellanza | Lombardy | 21053 | Italy |
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| Fondazione IRCCS Don Gnocchi | Not yet recruiting | Milan | Lombardy | 20148 | Italy |
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| Fondazione IRCCS San Gerardo dei Tintori [Recruiting] | Recruiting | Monza | Lombardy | 20900 | Italy |
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| Fondazione IRCCS Mondino | Not yet recruiting | Pavia | Lombardy | 27100 | Italy |
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| AOU Careggi | Not yet recruiting | Florence | Tuscany | 50134 | Italy |
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| AO Padova | Not yet recruiting | Padova | Veneto | MD, PhD | Italy |
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