REspectful CAring for the AGitated Elderly

• Conditions: Dementia

• Registration Number: NCT03507504
• Lead Sponsor: Fondazione Europea di Ricerca Biomedica Ferb Onlus

Brief Summary

The treatment of Behavioural and Psychological Symptoms of Dementia (BPSD) continue to raise difficult problems. Both the pharmacologic and non-pharmacologic therapies often fail to achieve the expected results. The aim of this study is to assess the short- and long-term efficacy of an intervention, the Special Care Unit for patients with BPSD (SCU-B), already implemented in some countries but not validated so far, as well as its cost-effectiveness

Detailed Description

Two cohorts of 250 patients each will be recruited by six clinical centres endowed with a SCU-B (one cohort) and six centres lacking this structure. The follow-up will last 3 years, during which patients will be visited every 6 months and submitted to a battery exploring the severity of the BPSD and the quality of life. All adverse events will be registered, as well as some anticipated occurrences (admissions to the general hospital for intercurrent diseases, admissions to a SCU-B pertaining to the clinical participating centre and, if any, admissions to a SCU-B not pertaining to the Consortium member, nursing home placement).

At the same time the quality of life of the primary caregivers will be measured, as well as their attitude toward dementia.

A cost-effectiveness analysis will be performed comparing the cohorts. Finally the time to the nursing home placement will be recorded and compared between the two cohorts

Study Timeline

• Study First Submitted: 2018-04-09
• Study First Submitted QC: 2018-04-15
• Study Start: 2018-04-19
• Study First Posted: 2018-04-25
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-08-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• diagnosis of primary dementia (DSM IV)
• MMSE score ≤ 24
• NPI global score ≥ 32/144
• a caregiver (informal/family member or formal caregiver) who commits her/himself to accompany the patient along the three-year course of the study
• living at home (nursing home residents are excluded).

Exclusion Criteria

• presence of uncontrolled medical disease potentially contributing to the cognitive decline and BPSD
• concomitant psychiatric disorders or chronic alcoholism
• concomitant diseases severe enough to reduce life expectancy < 6 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change of BPSD	baseline, 6, 12, 18, 24, 30, 36 months	Neuropsychiatric Inventory (NPI), range 0-144

Secondary Outcome Measures

Name	Time	Method
quality of life of patients	baseline, 6, 12,18, 24, 30, 36 months	Quality of Life Alzheimer's Disease (QoL-AD), range 0-52
quality of life of caregivers	baseline, 6, 12, 18, 24, 30, 36 months	Caregiver Burden Inventory (CBI), range 0-96
cost-effectiveness of SCU-B	baseline, 6, 12, 18, 24, 30, 36 months	Resource Utilisation in Dementia (RUD)

Trial Locations

Locations (12)

Centre Hospitalier Universitaire St Pierre; 🇧🇪 Bruxelles, Belgium

Assistance Publique - Hopitaux de Paris; 🇫🇷 Paris, France

Zentralinstitut für Seelische Gesundheit; 🇩🇪 Mannheim, Baden-Wurttenberg, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Aristotelio Panepistimio Thessalonikis (Greece); 🇬🇷 Thessaloníki, Greece

Cliniche Gavazzeni SpA; 🇮🇹 Bergamo, BG, Italy

Fondazione Europea di Ricerca Biomedica; 🇮🇹 Gazzaniga, BG, Italy

Azienda Socio Sanitaria Territoriale di Mantova; 🇮🇹 Mantova, MN, Italy

Azienda Unità Sanitaria Locale di Modena; 🇮🇹 Modena, MO, Italy

Università degli Studi di Perugia; 🇮🇹 Perugia, PG, Italy

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