REspectful CAring for the AGitated Elderly

Dementia Clinical Trial

— RECAGE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03507504
• Other study ID #: H2020 Proposal, number: 779237
• Status: Recruiting
• Start date: April 19, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2019
• Source: Fondazione Europea di Ricerca Biomedica Ferb Onlus
• Contact: Carla Finocchiaro, Ph.D.
• Phone: +390231083323
• Email: carla.finocchiaro[@]cf-c.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• SCU-B
SCU-B is "a residential medical structure lying outside of a nursing home, in a general hospital or elsewhere, e.g. in a private hospital, where patients with BPSD are temporarily admitted when their behavioural disturbances are not amenable to control at home".

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Universitaire St Pierre	Bruxelles
France	Assistance Publique - Hopitaux de Paris	Paris
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Zentralinstitut für Seelische Gesundheit	Mannheim	Baden-Wurttenberg
Greece	Aristotelio Panepistimio Thessalonikis (Greece)	Thessaloníki
Italy	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
Norway	Sykehuset Innlandet	Ottestad
Switzerland	Université de Genève	Genève

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Europea di Ricerca Biomedica Ferb Onlus	Mediolanum Cardio Research

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Greece,  Italy,  Norway,  Switzerland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	delayed institutionalisation	Time to nursing home placement	until 3 years
Primary	change of BPSD	Neuropsychiatric Inventory (NPI), range 0-144	baseline, 6, 12, 18, 24, 30, 36 months
Secondary	quality of life of patients	Quality of Life Alzheimer's Disease (QoL-AD), range 0-52	baseline, 6, 12,18, 24, 30, 36 months
Secondary	quality of life of caregivers	Caregiver Burden Inventory (CBI), range 0-96	baseline, 6, 12, 18, 24, 30, 36 months
Secondary	cost-effectiveness of SCU-B	Resource Utilisation in Dementia (RUD)	baseline, 6, 12, 18, 24, 30, 36 months