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REspectful CAring for the AGitated Elderly (RECAGE)

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ClinicalTrials.gov Identifier: NCT03507504
Recruitment Status : Not yet recruiting
First Posted : April 25, 2018
Last Update Posted : April 25, 2018
Sponsor:
Collaborator:
Mediolanum Cardio Research
Information provided by (Responsible Party):
Carlo Alberto Defanti, 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

Condition or disease Intervention/treatment
Dementia Other: SCU-B

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 Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Group/Cohort Intervention/treatment
care pathway with SCU-B
250 patients with dementia and behavioural and psychological symptoms of dementia (BPSD) followed up by six clinical centres with a Special Care Unit for BPSD (SCU-B)
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".

care pathway without SCU-B
250 patients with dementia and BPSD followed up by six clinical centres without SCU-B



Primary Outcome Measures :
  1. change of BPSD [ Time Frame: baseline, 6, 12, 18, 24, 30, 36 months ]
    Neuropsychiatric Inventory (NPI), range 0-144


Secondary Outcome Measures :
  1. quality of life of patients [ Time Frame: baseline, 6, 12,18, 24, 30, 36 months ]
    Quality of Life Alzheimer's Disease (QoL-AD), range 0-52

  2. quality of life of caregivers [ Time Frame: baseline, 6, 12, 18, 24, 30, 36 months ]
    Caregiver Burden Inventory (CBI), range 0-96

  3. cost-effectiveness of SCU-B [ Time Frame: baseline, 6, 12, 18, 24, 30, 36 months ]
    Resource Utilisation in Dementia (RUD)


Other Outcome Measures:
  1. delayed institutionalisation [ Time Frame: until 3 years ]
    Time to nursing home placement



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507504


Contacts
Contact: Carla Finocchiaro, Ph.D. +390231083323 carla.finocchiaro@cf-c.it
Contact: Sara Fascendini, M.D. +390353065206 recage@ferbonlus.com

Locations
Belgium
Centre Hospitalier Universitaire St Pierre Not yet recruiting
Bruxelles, Belgium
Contact: Jean P Praet, M.D.    +3225354118    jean-philippe_praet@stpierre-bru.be   
France
Assistance Publique - Hopitaux de Paris Not yet recruiting
Paris, France
Contact: Jacques Hugon, M.D.    +33149958484    jacques.hugon@inserm.fr   
Germany
Zentralinstitut für Seelische Gesundheit Not yet recruiting
Mannheim, Baden-Wurttenberg, Germany
Contact: Lutz Froelich, M.D.    +4962117033001    lutz.froelich@zi-mannheim.de   
Charité - Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany
Contact: Oliver Peters, M.D.    +4930450517942    oliver.peters@charite.de   
Greece
Aristotelio Panepistimio Thessalonikis (Greece) Not yet recruiting
Thessaloníki, Greece
Contact: Magda Tsolaki, M.D.       tsolakim1@gmail.com   
Contact    +302310234239      
Italy
Cliniche Gavazzeni SpA Not yet recruiting
Bergamo, BG, Italy
Contact: Paola Merlo, M.D.    +390354204668    paola.merlo@gavazzeni.it   
Fondazione Europea di Ricerca Biomedica Not yet recruiting
Gazzaniga, BG, Italy, 24020
Contact: Sara Fascendini, M.D.    +390353065206    recage@ferbonlus.com   
Contact: Federica Barocco, M.D.    +390353065206    federica.barocco@ferbonlus.com   
Azienda Socio Sanitaria Territoriale di Mantova Not yet recruiting
Mantova, MN, Italy
Contact: Alfonso Ciccone, M.D.    +390376201543    alfonso.ciccone@asst-mantova.it   
Azienda Unità Sanitaria Locale di Modena Not yet recruiting
Modena, MO, Italy
Contact: Andrea Fabbo, M.D.    +39059435201    a.fabbo@ausl.mo.it   
Università degli Studi di Perugia Not yet recruiting
Perugia, PG, Italy
Contact: Patrizia Mecocci, M.D.    +390755783270    patrizia.mecocci@unipg.it   
Norway
Sykehuset Innlandet Not yet recruiting
Ottestad, Norway
Contact: Sverre Bergh, M.D.    +4745679393    sverre.bergh@sykehuset-innlandet.no   
Switzerland
Université de Genève Not yet recruiting
Genève, Switzerland
Contact: Giovanni B Frisoni, M.D.    +410223055762    giovanni.frisoni@gmail.com   
Sponsors and Collaborators
Fondazione Europea di Ricerca Biomedica Ferb Onlus
Mediolanum Cardio Research
Investigators
Study Director: Carlo A Defanti, M.D. Fondazione Europea di Ricerca Biomedica

Publications:
Responsible Party: Carlo Alberto Defanti, Study Coordinator, Fondazione Europea di Ricerca Biomedica Ferb Onlus
ClinicalTrials.gov Identifier: NCT03507504     History of Changes
Other Study ID Numbers: H2020 Proposal, number: 779237
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified participant data both for primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will be available six months after study completion
Access Criteria: Data access requests will be reviewed by an independent Data Safety Monitoring Board

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carlo Alberto Defanti, Fondazione Europea di Ricerca Biomedica Ferb Onlus:
psychiatric aspects

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders