Clinical trial NCT03507504: REspectful CAring for the AGitated Elderly
Official title: REspectful CAring for the AGitated Elderly. How to Best Meet the Needs of People With Dementia With Severe Behavioural Disturbances. Toward a Respectful and Cost-effective Model
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dementia
Keywords: psychiatric aspects
Lead sponsor: Fondazione Europea di Ricerca Biomedica Ferb Onlus
Sponsor class: OTHER
Collaborators: name: Mediolanum Cardio Research
First posted: 2018-04-25
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population studied is made by the outpatients with dementia referred to the memory clinics of 12 clinical centres located in seven European countries (Italy, Germany, France, Belgium, Greece, Switzerland, Norway)

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

Eligibility criteria: 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

Primary outcomes:
measure: change of BPSD
timeFrame: baseline, 6, 12, 18, 24, 30, 36 months
Secondary outcomes:
measure: quality of life of patients
timeFrame: baseline, 6, 12,18, 24, 30, 36 months
measure: quality of life of caregivers
timeFrame: baseline, 6, 12, 18, 24, 30, 36 months
measure: cost-effectiveness of SCU-B
timeFrame: baseline, 6, 12, 18, 24, 30, 36 months
Other outcomes:
measure: delayed institutionalisation
timeFrame: until 3 years
Locations:
city: Bruxelles
country: Belgium
facility: Centre Hospitalier Universitaire St Pierre
city: Paris
country: France
facility: Assistance Publique - Hopitaux de Paris
city: Mannheim
country: Germany
facility: Zentralinstitut für Seelische Gesundheit
state: Baden-Wurttenberg
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Thessaloníki
country: Greece
facility: Aristotelio Panepistimio Thessalonikis (Greece)
city: Bergamo
country: Italy
facility: Cliniche Gavazzeni SpA
state: BG
city: Gazzaniga
country: Italy
facility: Fondazione Europea di Ricerca Biomedica
state: BG
city: Mantova
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Mantova
state: MN
city: Modena
country: Italy
facility: Azienda Unità Sanitaria Locale di Modena
state: MO
city: Perugia
country: Italy
facility: Università degli Studi di Perugia
state: PG
city: Ottestad
country: Norway
facility: Sykehuset Innlandet
city: Genève
country: Switzerland
facility: Université de Genève
Study officials:
affiliation: Fondazione Europea di Ricerca Biomedica
name: Carlo A Defanti, M.D.
role: STUDY_DIRECTOR
References:
citation: Koskas P, Belqadi S, Mazouzi S, Daraux J, Drunat O. [Behavioral and psychological symptoms of dementia in a pilot psychogeriatric unit: management and outcomes]. Rev Neurol (Paris). 2011 Mar;167(3):254-9. doi: 10.1016/j.neurol.2010.07.030. Epub 2010 Oct 14. French.
citation: Delphin-Combe F, Roubaud C, Martin-Gaujard G, Fortin ME, Rouch I, Krolak-Salmon P. [Effectiveness of a cognitive-behavioral unit on behavioral and psychological symptoms of dementia]. Rev Neurol (Paris). 2013 Jun-Jul;169(6-7):490-4. doi: 10.1016/j.neurol.2012.10.017. Epub 2013 Mar 21. French.
citation: Bianchetti A, Benvenuti P, Ghisla KM, Frisoni GB, Trabucchi M. An Italian model of dementia special care unit: results of a pilot study. Alzheimer Dis Assoc Disord. 1997 Mar;11(1):53-6. doi: 10.1097/00002093-199703000-00009.