DementiaRECAGENCT03507504
REspectful CAring for the AGitated Elderly
An observational study of Dementia, run by Fondazione Europea di Ricerca Biomedica Ferb Onlus at 12 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- SCU-B
- How many people
- 500 participants
- Where
- 12 sitesin 7 countries
- Study dates
- 19 Apr 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
12 sites in 7 countries.
12 sites in 7 countries
Italy5 sites, 5 recruiting
- Not yet recruiting
Cliniche Gavazzeni SpA
Bergamo, BG
Paola Merlo, M.D., +390354204668, paola.merlo@gavazzeni.it
- Recruiting
Fondazione Europea di Ricerca Biomedica
Gazzaniga, BG, 24020
Sara Fascendini, M.D., +390353065206, recage@ferbonlus.com
Federica Barocco, M.D., +390353065206, federica.barocco@ferbonlus.com
- Recruiting
Azienda Socio Sanitaria Territoriale di Mantova
Mantua, MN
Alfonso Ciccone, M.D., +390376201543, alfonso.ciccone@asst-mantova.it
- Not yet recruiting
Azienda Unità Sanitaria Locale di Modena
Modena, MO
Andrea Fabbo, M.D., +39059435201, a.fabbo@ausl.mo.it
- Not yet recruiting
Università degli Studi di Perugia
Perugia, PG
Patrizia Mecocci, M.D., +390755783270, patrizia.mecocci@unipg.it
Germany2 sites, 2 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin
Oliver Peters, M.D., +4930450517942, oliver.peters@charite.de
- Not yet recruiting
Zentralinstitut für Seelische Gesundheit
Mannheim, Baden-Wurttenberg
Lutz Froelich, M.D., +4962117033001, lutz.froelich@zi-mannheim.de
Belgium1 site, 1 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire St Pierre
Brussels
Jean P Praet, M.D., +3225354118, jean-philippe_praet@stpierre-bru.be
France1 site, 1 recruiting
- Not yet recruiting
Assistance Publique - Hopitaux de Paris
Paris
Jacques Hugon, M.D., +33149958484, jacques.hugon@inserm.fr
Greece1 site, 1 recruiting
- Recruiting
Aristotelio Panepistimio Thessalonikis (Greece)
Thessaloniki
Magda Tsolaki, M.D., tsolakim1@gmail.com
+302310234239
Norway1 site, 1 recruiting
- Not yet recruiting
Sykehuset Innlandet
Ottestad
Sverre Bergh, M.D., +4745679393, sverre.bergh@sykehuset-innlandet.no
Switzerland1 site, 1 recruiting
- Not yet recruiting
Université de Genève
Geneva
Giovanni B Frisoni, M.D., +410223055762, giovanni.frisoni@gmail.com
About this study
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
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
Read the 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
- Conditions
- Dementia
- Being tested
- SCU-B
- Keywords
- psychiatric aspects
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCU-BOther
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".
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: SCU-B | |
| care pathway without SCU-B | 250 patients with dementia and BPSD followed up by six clinical centres without SCU-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of BPSD
Neuropsychiatric Inventory (NPI), range 0-144
Measured: baseline, 6, 12, 18, 24, 30, 36 months
Secondary outcomes (3)
quality of life of patients
Quality of Life Alzheimer's Disease (QoL-AD), range 0-52
Measured: baseline, 6, 12,18, 24, 30, 36 months
quality of life of caregivers
Caregiver Burden Inventory (CBI), range 0-96
Measured: baseline, 6, 12, 18, 24, 30, 36 months
cost-effectiveness of SCU-B
Resource Utilisation in Dementia (RUD)
Measured: baseline, 6, 12, 18, 24, 30, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start19 Apr 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Europea di Ricerca Biomedica Ferb Onlus
- Sponsor type
- University, hospital or other
- Collaborators
- Mediolanum Cardio Research
- Responsible party
- Principal investigator, Carlo Alberto Defanti, Fondazione Europea di Ricerca Biomedica Ferb Onlus
- Investigators
- Carlo A Defanti, M.D., Study director, Fondazione Europea di Ricerca Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507504
- Sponsor's protocol ID
- H2020 Proposal, number: 779237
- Acronym
- RECAGE
- Status last verified
- Jul 2019
- First submitted
- 9 Apr 2018
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data both for primary and secondary outcome measures will be made available
Publications
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.
PubMed 20947112Delphin-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.
PubMed 23523558Bianchetti 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.
PubMed 9071445Cesana BM, Bergh S, Ciccone A, Cognat E, Fabbo A, Fascendini S, Frisoni GB, Froelich L, Handels R, Jori MC, Mecocci P, Merlo P, Peters O, Tsolaki M, Defanti CA. Predictors of Nursing Home Placement in a Cohort of European People with Alzheimer's Disease and Other Dementia Cases Enrolled in SCU-B or Non SCU-B Centers: The RECage Study. J Alzheimers Dis. 2024;98(3):1043-1052. doi: 10.3233/JAD-230878.
PubMed 38489173
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03507504
- Acronym / sponsor ID
- RECAGE / H2020 Proposal, number: 779237
- Conditions
- Dementia
- Keywords
- psychiatric aspects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fondazione Europea di Ricerca Biomedica Ferb OnlusUniversity, hospital or other
- Collaborators
- Mediolanum Cardio Research
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| care pathway with SCU-B | – | Other: SCU-B250 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) |
| care pathway without SCU-B | – | –250 patients with dementia and BPSD followed up by six clinical centres without SCU-B |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCU-BSCU-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". | Other | care pathway with SCU-B |
Primary outcome
change of BPSD
Time frame: baseline, 6, 12, 18, 24, 30, 36 months
Neuropsychiatric Inventory (NPI), range 0-144
3 secondary outcomes
quality of life of patients
Time frame: baseline, 6, 12,18, 24, 30, 36 months
quality of life of caregivers
Time frame: baseline, 6, 12, 18, 24, 30, 36 months
cost-effectiveness of SCU-B
Time frame: baseline, 6, 12, 18, 24, 30, 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Background: PubMed 20947112Koskas 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.
- Background: PubMed 23523558Delphin-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.
- Background: PubMed 9071445Bianchetti 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.
- Derived from this study: PubMed 38489173Cesana BM, Bergh S, Ciccone A, Cognat E, Fabbo A, Fascendini S, Frisoni GB, Froelich L, Handels R, Jori MC, Mecocci P, Merlo P, Peters O, Tsolaki M, Defanti CA. Predictors of Nursing Home Placement in a Cohort of European People with Alzheimer's Disease and Other Dementia Cases Enrolled in SCU-B or Non SCU-B Centers: The RECage Study. J Alzheimers Dis. 2024;98(3):1043-1052. doi: 10.3233/JAD-230878.
- Individual participant dataSharing planned: Yes. De-identified participant data both for primary and secondary outcome measures will be made available
Related trials for Dementia
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Not yet recruiting
A Hybrid Effectiveness-Implementation and Cost-Utility Evaluation of a Support Programme for Informal Carers of People With Dementia in Primary Care (EsCuidar2)
Quality of Life
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo A Defanti, M.D. study director
Fondazione Europea di Ricerca Biomedica
12 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Fondazione Europea di Ricerca Biomedica Ferb Onlus at 12 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy, Germany, Belgium, France, Greece and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carla Finocchiaro, Ph.D. (+390231083323, carla.finocchiaro@cf-c.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of BPSD (time frame: baseline, 6, 12, 18, 24, 30, 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03507504, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.